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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91148

94 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 09, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Biomerieux Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

94 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 94

API LISTERIA 10 STRIPS+10 MEDIA, CATALOG 10300

Z-0783-2023
Recall number
Z-0783-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
5 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026035587, Batch Number 1009418280

Distribution pattern

US Nationwide distribution.

device · product 2 of 94

API 20 E 25 STRIPS, CATALOG 20100

Z-0784-2023
Recall number
Z-0784-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026047818, Batch Number 1009226560

Distribution pattern

US Nationwide distribution.

device · product 3 of 94

API 20 C AUX 25 STRIPS+25 MEDIA, CATALOG 20210

Z-0785-2023
Recall number
Z-0785-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026048082, Batch Number 1009373680

Distribution pattern

US Nationwide distribution.

device · product 4 of 94

API STAPH 25 STRIPS+25 MEDIA, CATALOG 20500

Z-0786-2023
Recall number
Z-0786-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026048259, Batch Number 1009395530

Distribution pattern

US Nationwide distribution.

device · product 5 of 94

VITEK 2 REAGENT GN TEST KIT VTK2 20 CARDS, CATALOG 21341

Z-0787-2023
Recall number
Z-0787-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
348 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026131913, Batch Numbers: 2412101403, 2412103403, 2412103503, 2412106403

Distribution pattern

US Nationwide distribution.

device · product 6 of 94

VITEK 2 REAGENT GP TEST KIT VTK2 20 CARDS, CATALOG 21342

Z-0788-2023
Recall number
Z-0788-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
144 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026131920, Batch Numbers: 2422281503, 2422288503

Distribution pattern

US Nationwide distribution.

device · product 7 of 94

VITEK 2 REAGENT YST TEST KIT VTK2 20 CARDS, CATALOG 21343

Z-0789-2023
Recall number
Z-0789-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
14 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026131937, Batch Numbers: 2432261103

Distribution pattern

US Nationwide distribution.

device · product 8 of 94

VITEK 2 REAGENT BCL TEST KIT VTK2 20 CARDS, CATALOG 21345

Z-0790-2023
Recall number
Z-0790-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 353026131951, Batch Numbers: 2392195203

Distribution pattern

US Nationwide distribution.

device · product 9 of 94

VITEK 2 REAGENT NH TEST KIT VTK2 20 CARDS, CATALOG 21346

Z-0791-2023
Recall number
Z-0791-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
13 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026144357, Batch Numbers: 2452278203

Distribution pattern

US Nationwide distribution.

device · product 10 of 94

VITEK 2 REAGENT AST-GP67 TEST KIT 20 CARDS, CATALOG 22226

Z-0792-2023
Recall number
Z-0792-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
15 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026242060, Batch Numbers: 1322258403

Distribution pattern

US Nationwide distribution.

device · product 11 of 94

PREVI COLOR GRAM REAGENT IODINE-B (NA), CATALOG 29586

Z-0793-2023
Recall number
Z-0793-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
10 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026263140, Batch Numbers: 230438

Distribution pattern

US Nationwide distribution.

device · product 12 of 94

PREVI COLOR GRAM REAGENT NOZZLE CLEANING SOLUTION (NA), CATALOG 29588

Z-0794-2023
Recall number
Z-0794-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026263164, Batch Numbers: 229478

Distribution pattern

US Nationwide distribution.

device · product 13 of 94

VIDAS CLINICALVIDAS VARICEL. ZOSTER IGG 60 T, CATALOG 30217

Z-0795-2023
Recall number
Z-0795-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026064518, Batch Numbers: 229478

Distribution pattern

US Nationwide distribution.

device · product 14 of 94

VIDAS CLINICAL VIDAS MEASLES IGG 60TESTS, CATALOG 30219

Z-0796-2023
Recall number
Z-0796-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
5 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026064532, Batch Numbers: 1009421810

Distribution pattern

US Nationwide distribution.

device · product 15 of 94

VIDAS CLINICAL VIDAS RUB IGG 60 TESTS, CATALOG 30226

Z-0797-2023
Recall number
Z-0797-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026138585, Batch Numbers: 1009370850

Distribution pattern

US Nationwide distribution.

device · product 16 of 94

VIDAS CLINICAL VIDAS LISTERIA 60T, CATALOG 30700

Z-0798-2023
Recall number
Z-0798-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
10 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026065850, Batch Numbers: 1009371140

Distribution pattern

US Nationwide distribution.

device · product 17 of 94

VIDAS CLINICAL VIDAS SALMONELLA 60T, CATALOG 30702

Z-0799-2023
Recall number
Z-0799-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
15 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026065874, Batch Numbers: 1009406530

Distribution pattern

US Nationwide distribution.

device · product 18 of 94

VIDAS CLINICAL QCV-QUALITY CONTROL VIDAS 60T, CATALOG 30706

Z-0800-2023
Recall number
Z-0800-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
12 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026121631, Batch Numbers: 1009351560

Distribution pattern

US Nationwide distribution.

device · product 19 of 94

PPM CLINICAL CRAPONNE CLINICAL CHROMID CANDIDA 20 PLATES, CATALOG 43631

Z-0801-2023
Recall number
Z-0801-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
10 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026118969, Batch Numbers: 1009532350

Distribution pattern

US Nationwide distribution.

device · product 20 of 94

PPM CLINICAL CHROMID MRSA 20 PLT US, CATALOG 43841

Z-0802-2023
Recall number
Z-0802-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
84 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026313111, Batch Numbers: 1009525720, 1009530050

Distribution pattern

US Nationwide distribution.

device · product 21 of 94

PPM CLINICAL CRAPONNE CHROMID VRE 20 PLT US, CATALOG 43851

Z-0803-2023
Recall number
Z-0803-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026313128, Batch Numbers: 1009540400

Distribution pattern

US Nationwide distribution.

device · product 22 of 94

PPM CLINICAL CRAPONNE CHROMID C.DIFFICILE 20 PLT, CATALOG 43871

Z-0804-2023
Recall number
Z-0804-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026316969, Batch Numbers: 1009501430

Distribution pattern

US Nationwide distribution.

device · product 23 of 94

BIOBALL A.BRASILIENSIS NCPF 2275 550X20, CATALOG 56011

Z-0805-2023
Recall number
Z-0805-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026228194, Batch Numbers: 7112

Distribution pattern

US Nationwide distribution.

device · product 24 of 94

BIOBALL B.SPIZIZENII NCTC 10400 550X20, CATALOG 56012

Z-0806-2023
Recall number
Z-0806-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026228200, Batch Numbers: 7190

Distribution pattern

US Nationwide distribution.

device · product 25 of 94

BIOBALL P.AERUGINOSA NCTC 12924 550X20, CATALOG 56017

Z-0807-2023
Recall number
Z-0807-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026228255, Batch Numbers: 7240

Distribution pattern

US Nationwide distribution.

device · product 26 of 94

API VP1 VP2 REAGENTS, CATALOG 70422

Z-0808-2023
Recall number
Z-0808-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026099626, Batch Numbers: 1009393450

Distribution pattern

US Nationwide distribution.

device · product 27 of 94

API NIT1 NIT2 REAGENTS, CATALOG 70442

Z-0809-2023
Recall number
Z-0809-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026099671, Batch Numbers: 1009326520

Distribution pattern

US Nationwide distribution.

device · product 28 of 94

API JAMES 2AMP, CATALOG 70542

Z-0810-2023
Recall number
Z-0810-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026099893, Batch Numbers: 1009360510

Distribution pattern

US Nationwide distribution.

device · product 29 of 94

TEMPO REAGENTS TEMPO CONTROL KIT , CATALOG 80000

Z-0811-2023
Recall number
Z-0811-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026128142, Batch Numbers: 1009477900

Distribution pattern

US Nationwide distribution.

device · product 30 of 94

ASTUTE REAGENT ASTUTE ELECTRONIC QUALITY CTRL DEVICE US, CATALOG 400016

Z-0812-2023
Recall number
Z-0812-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
5 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026565541, Batch Numbers: 21EQC0163I, 21EQC0162I, 21EQC0160I, 21EQC0158I, 21EQC0174I

Distribution pattern

US Nationwide distribution.

device · product 31 of 94

PPM INDUSTRY COMBOURG LPT BROTH (4X3L), CATALOG 410849

Z-0813-2023
Recall number
Z-0813-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
4 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026357849, Batch Numbers: 2117760, 2120100

Distribution pattern

US Nationwide distribution.

device · product 32 of 94

VITEK MS CLINICAL REAGENT VITEK MS-DS, CATALOG 410893

Z-0814-2023
Recall number
Z-0814-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
13 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026359096, Batch Numbers: 11111288BM

Distribution pattern

US Nationwide distribution.

device · product 33 of 94

VITEK MS CLINICAL REAGENT VITEK MS-CHCA, CATALOG 411071

Z-0815-2023
Recall number
Z-0815-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
46 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

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Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026362836, Batch Numbers: 1009391190, 1009434380, 1009472100

Distribution pattern

US Nationwide distribution.

device · product 34 of 94

VITEK MS CLINICAL REAGENT VITEK MS-FA, CATALOG 411072

Z-0816-2023
Recall number
Z-0816-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
29 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026362843, Batch Numbers: 1009346190

Distribution pattern

US Nationwide distribution.

device · product 35 of 94

ETEST CLINICAL AMIKACIN AK 256 US S30, CATALOG 412218

Z-0817-2023
Recall number
Z-0817-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026376567, Batch Numbers: 1009209480

Distribution pattern

US Nationwide distribution.

device · product 36 of 94

ETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30, CATALOG 412240

Z-0818-2023
Recall number
Z-0818-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026376581, Batch Numbers: 1009190560

Distribution pattern

US Nationwide distribution.

device · product 37 of 94

ETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30, CATALOG 412252

Z-0819-2023
Recall number
Z-0819-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026376703, Batch Numbers: 1009311920

Distribution pattern

US Nationwide distribution.

device · product 38 of 94

ETEST CLINICAL BENZYLPENICIL PG 256 US S30, CATALOG 412262

Z-0820-2023
Recall number
Z-0820-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026376802, Batch Numbers: 1009477980

Distribution pattern

US Nationwide distribution.

device · product 39 of 94

ETEST CLINICAL CEFTRIAXONE TX 32 US S30, CATALOG 412302

Z-0821-2023
Recall number
Z-0821-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026377205, Batch Numbers: 1009444340

Distribution pattern

US Nationwide distribution.

device · product 40 of 94

ETEST CLINICAL ERTAPENEM ETP 32 US S30, CATALOG 412331

Z-0822-2023
Recall number
Z-0822-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
5 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026377533, Batch Numbers: 1009491830

Distribution pattern

US Nationwide distribution.

device · product 41 of 94

ETEST CLINICAL ERYTHROMYCIN EM 256 US S30, CATALOG 412333

Z-0823-2023
Recall number
Z-0823-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
5 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026377557, Batch Numbers: 1009157090

Distribution pattern

US Nationwide distribution.

device · product 42 of 94

ETEST CLINICAL FLUCONAZOLE FL 256 US S30, CATALOG 412333

Z-0824-2023
Recall number
Z-0824-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026377717, Batch Numbers: 1009172020

Distribution pattern

US Nationwide distribution.

device · product 43 of 94

ETEST CLINICAL IMIPENEM IP 32 US S30, CATALOG 412373

Z-0825-2023
Recall number
Z-0825-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026377953, Batch Numbers: 1009371780

Distribution pattern

US Nationwide distribution.

device · product 44 of 94

ETEST CLINICAL LEVOFLOXACIN LE 32 US S30, CATALOG 412392

Z-0826-2023
Recall number
Z-0826-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
7 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026378073, Batch Numbers: 1009240000

Distribution pattern

US Nationwide distribution.

device · product 45 of 94

ETEST CLINICAL MEROPENEM MP 32 US S30, CATALOG 412401

Z-0827-2023
Recall number
Z-0827-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
3 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026378165, Batch Numbers: 03573026378165, 03573026378165

Distribution pattern

US Nationwide distribution.

device · product 46 of 94

ETEST CLINICAL MINOCYCLINE MC 256 US S30, CATALOG 412407

Z-0828-2023
Recall number
Z-0828-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
3 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026378226, Batch Numbers: 1009434000

Distribution pattern

US Nationwide distribution.

device · product 47 of 94

ETEST CLINICAL RIFAMPICIN RI 32 US S30, CATALOG 412449

Z-0829-2023
Recall number
Z-0829-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026378592, Batch Numbers: 1009190620

Distribution pattern

US Nationwide distribution.

device · product 48 of 94

ETEST CLINICAL TOBRAMYCIN TM 256 US S30, CATALOG 412478

Z-0830-2023
Recall number
Z-0830-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
4 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026378875, Batch Numbers: 1009434160

Distribution pattern

US Nationwide distribution.

device · product 49 of 94

ETEST CLINICAL VANCOMYCIN VA 256 US S30, CATALOG 412486

Z-0831-2023
Recall number
Z-0831-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
7 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026378950, Batch Numbers: 1009432150

Distribution pattern

US Nationwide distribution.

device · product 50 of 94

BIOBALL K.RHIZOPHILA (30X20), CATALOG 412690

Z-0832-2023
Recall number
Z-0832-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026381103, Batch Numbers: 7408

Distribution pattern

US Nationwide distribution.

device · product 51 of 94

VITEK 2 REAGENT AST-GN69 TEST KIT 20 CARDS, CATALOG 413400

Z-0833-2023
Recall number
Z-0833-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
30 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026398460, Batch Numbers: 5892256103

Distribution pattern

US Nationwide distribution.

device · product 52 of 94

VITEK 2 REAGENT AST-GN70 TEST KIT 20 CARDS, CATALOG 413401

Z-0834-2023
Recall number
Z-0834-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
120 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026398477, Batch Numbers: 5902225503, 5902279403

Distribution pattern

US Nationwide distribution.

device · product 53 of 94

VITEK 2 REAGENT AST-GN73 TEST KIT 20 CARDS, CATALOG 413404

Z-0835-2023
Recall number
Z-0835-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
64 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026398507, Batch Numbers: 5932237403

Distribution pattern

US Nationwide distribution.

device · product 54 of 94

VITEK 2 REAGENT AST-GN79 TEST KIT 20 CARDS, CATALOG 413436

Z-0836-2023
Recall number
Z-0836-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
310 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026399016, Batch Numbers: 5992201403, 5992253503

Distribution pattern

US Nationwide distribution.

device · product 55 of 94

VITEK 2 REAGENT AST-GN80 TEST KIT 20 CARDS, CATALOG 413437

Z-0837-2023
Recall number
Z-0837-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
15 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026399023, Batch Numbers: 6702239503

Distribution pattern

US Nationwide distribution.

device · product 56 of 94

VITEK 2 REAGENT AST-GN81 TEST KIT 20 CARDS, CATALOG 413438

Z-0838-2023
Recall number
Z-0838-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
34 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026399030, Batch Numbers: 6712257403

Distribution pattern

US Nationwide distribution.

device · product 57 of 94

PPM INDUSTRY COMBOURG CHROMID CARBA US 20 PLT, CATALOG 414012

Z-0839-2023
Recall number
Z-0839-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026409913 , Batch Numbers: 2147080

Distribution pattern

US Nationwide distribution.

device · product 58 of 94

GENE-UP REAGENT GENE-UP LYSIS KIT, CATALOG 414057

Z-0840-2023
Recall number
Z-0840-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 3573026387761, Batch Numbers: 1009334990

Distribution pattern

US Nationwide distribution.

device · product 59 of 94

ETEST CLINICAL CEFTOLOZANE/TAZO C/T US S30, CATALOG 414445

Z-0841-2023
Recall number
Z-0841-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
6 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026418748, Batch Numbers: 1009420460

Distribution pattern

US Nationwide distribution.

device · product 60 of 94

PPM CLINICAL CHROMID MRSA S AUREUS 20PLT US, CATALOG 414524

Z-0842-2023
Recall number
Z-0842-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
6 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026420758, Batch Numbers: 1009550310

Distribution pattern

US Nationwide distribution.

device · product 61 of 94

VITEK 2 REAGENT AST-GP75 TEST KIT 20 CARDS, CATALOG 415670

Z-0843-2023
Recall number
Z-0843-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
218 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026437183, Batch Numbers: 2752252403

Distribution pattern

US Nationwide distribution.

device · product 62 of 94

PPM LOMBARD PRODUCTS IRR COUNT-TACT 3P AGAR 100 PLT, CATALOG 418049

Z-0844-2023
Recall number
Z-0844-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
8 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026466435, Batch Numbers: 1009462900

Distribution pattern

US Nationwide distribution.

device · product 63 of 94

PPM LOMBARD PRODUCTS TSA 3P W NEUTRALIZERS 100 PLT, CATALOG 419014

Z-0845-2023
Recall number
Z-0845-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
7 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026493868, Batch Numbers: 1009498140

Distribution pattern

US Nationwide distribution.

device · product 64 of 94

ETEST CLINICAL CEFTAZIDIM/AVIBACTAM US S30, CATALOG 419046

Z-0846-2023
Recall number
Z-0846-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
8 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026494537, Batch Numbers: 1009384490

Distribution pattern

US Nationwide distribution.

device · product 65 of 94

PPM CLINICAL CHROMID STREPTO B US 20 PLT, CATALOG 419751

Z-0847-2023
Recall number
Z-0847-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
6 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026505684, Batch Numbers: 1009534170

Distribution pattern

US Nationwide distribution.

device · product 66 of 94

VITEK 2 REAGENT AST-ST02 TEST KIT 20 CARDS, CATALOG 420915

Z-0848-2023
Recall number
Z-0848-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
39 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

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Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026552152, Batch Numbers: 5412237203

Distribution pattern

US Nationwide distribution.

device · product 67 of 94

ETEST CLINICAL IMIPENEM RELEBACTAM IPR US S30, CATALOG 420927

Z-0849-2023
Recall number
Z-0849-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026551544, Batch Numbers: 1008988170

Distribution pattern

US Nationwide distribution.

device · product 68 of 94

VITEK 2 REAGENT AST-GP78 TEST KIT 20 CARDS, CATALOG 421051

Z-0850-2023
Recall number
Z-0850-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
26 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026553982, Batch Numbers: 2782225503

Distribution pattern

US Nationwide distribution.

device · product 69 of 94

ETEST CLINICAL ERAVACYCLINE ERV US S30, CATALOG 421553

Z-0851-2023
Recall number
Z-0851-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026560997, Batch Numbers: 1009288050

Distribution pattern

US Nationwide distribution.

device · product 70 of 94

ETEST CLINICAL ETEST MEROPENEM/VABORBACTAM MEV US S30, CATALOG 421560

Z-0852-2023
Recall number
Z-0852-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
6 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026560690, Batch Numbers: 1008848690

Distribution pattern

US Nationwide distribution.

device · product 71 of 94

VITEK 2 REAGENT AST-GN95 TEST KIT 20 CARDS, CATALOG 421982

Z-0853-2023
Recall number
Z-0853-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
84 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026565923, Batch Numbers: 6852245503

Distribution pattern

US Nationwide distribution.

device · product 72 of 94

VITEK 2 REAGENT AST-GN99 TEST KIT 20 CARDS, CATALOG 423102

Z-0854-2023
Recall number
Z-0854-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
187 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026608132, Batch Numbers: 6892251103

Distribution pattern

US Nationwide distribution.

device · product 73 of 94

GENE-UP REAGENT GENE-UP Salmonella 2, CATALOG 423105

Z-0855-2023
Recall number
Z-0855-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026608514, Batch Numbers: 1009407250

Distribution pattern

US Nationwide distribution.

device · product 74 of 94

VITEK 2 REAGENT AST-N801 TEST KIT 20 CARDS, CATALOG 423416

Z-0856-2023
Recall number
Z-0856-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
64 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026618834, Batch Numbers: 412148504

Distribution pattern

US Nationwide distribution.

device · product 75 of 94

VITEK 2 REAGENT AST-XN09 TEST KIT 20 CARDS, CATALOG 423425

Z-0857-2023
Recall number
Z-0857-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
50 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026618940, Batch Numbers: 3122253113

Distribution pattern

US Nationwide distribution.

device · product 76 of 94

PPM LOMBARD PRODUCTS TSA 3P W NEUTRALIZERS 100 PLT, CATALOG 423723

Z-0858-2023
Recall number
Z-0858-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
74 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026618018, Batch Numbers: 1009552660

Distribution pattern

US Nationwide distribution.

device · product 77 of 94

ETEST CLINICAL ETEST MEROPENEM MP M100 US, CATALOG 423786

Z-0859-2023
Recall number
Z-0859-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026618766, Batch Numbers: 1009462290

Distribution pattern

US Nationwide distribution.

device · product 78 of 94

ETEST CLINICAL ETEST VANCOMYCIN VA M100 US, CATALOG 423788

Z-0860-2023
Recall number
Z-0860-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026618780, Batch Numbers: 1009351550

Distribution pattern

US Nationwide distribution.

device · product 79 of 94

VITEK 2 REAGENT AST-XN15 TEST KIT 20 CARDS, CATALOG 423829

Z-0861-2023
Recall number
Z-0861-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
58 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026620288, Batch Numbers: 8312243203

Distribution pattern

US Nationwide distribution.

device · product 80 of 94

ASTUTE REAGENT NEPHROCHECK LIQUID CONTROLS KIT US, CATALOG 500013

Z-0862-2023
Recall number
Z-0862-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
3 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026565503, Batch Numbers: 22LCK0024G

Distribution pattern

US Nationwide distribution.

device · product 81 of 94

ETEST CLINICAL COLISTIN CO 256 US B100, CATALOG 537348

Z-0863-2023
Recall number
Z-0863-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026254681, Batch Numbers: 1009261260, Research use only

Distribution pattern

US Nationwide distribution.

device · product 82 of 94

VIDAS CLINICAL VIDAS HCG 60 TESTS, CATALOG 30405-01

Z-0864-2023
Recall number
Z-0864-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
4 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026156923, Batch Numbers: 1009527770

Distribution pattern

US Nationwide distribution.

device · product 83 of 94

VIDAS CLINICAL VIDAS LH 60 TESTS, CATALOG 30406-01

Z-0865-2023
Recall number
Z-0865-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
4 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026156930, Batch Numbers: 1009483380

Distribution pattern

US Nationwide distribution.

device · product 84 of 94

VIDAS CLINICAL VIDAS PROGESTERONE 60 TESTS, CATALOG 30409-01

Z-0866-2023
Recall number
Z-0866-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
6 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026156954, Batch Numbers: 1009375960

Distribution pattern

US Nationwide distribution.

device · product 85 of 94

VIDAS CLINICAL VIDAS ESTRADIOL II 60 TESTS, CATALOG 30431-01

Z-0867-2023
Recall number
Z-0867-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
7 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026161637, Batch Numbers: 1009378680

Distribution pattern

US Nationwide distribution.

device · product 86 of 94

VIDAS CLINICAL VIDAS BRAHMS PROCALCITONIN 60T, CATALOG 30450-01

Z-0868-2023
Recall number
Z-0868-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
47 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026223601, Batch Numbers: 1009301530

Distribution pattern

US Nationwide distribution.

device · product 87 of 94

DCOUNT SYSTEMS REAGENTS CHEMCHROME V14 (6X1.8ML), CATALOG 306-R1026-01

Z-0869-2023
Recall number
Z-0869-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
14 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03661901000857, Batch Numbers: 3073090

Distribution pattern

US Nationwide distribution.

device · product 88 of 94

PPM INDUSTRY COMBOURG BACARA 20PLATES 90MM, CATALOG AEB520100

Z-0870-2023
Recall number
Z-0870-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
10 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03661901005531, Batch Numbers: 2134340

Distribution pattern

US Nationwide distribution.

device · product 89 of 94

PPM LOMBARD PRODUCTS CT&IR&DB-TSA + L & P80 10PLT, CATALOG C6045-IR

Z-0871-2023
Recall number
Z-0871-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
60 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026319946, Batch Numbers: 1009524320

Distribution pattern

US Nationwide distribution.

device · product 90 of 94

PPM LOMBARD PRODUCTS CT&TI-TSA + L & P80 10PLT, CATALOG C6045-TI

Z-0872-2023
Recall number
Z-0872-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
20 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026319953, Batch Numbers: 1009389930

Distribution pattern

US Nationwide distribution.

device · product 91 of 94

PPM LOMBARD PRODUCTS TSA 10PLT, CATALOG M1040

Z-0873-2023
Recall number
Z-0873-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026320362, Batch Numbers: 1009527240

Distribution pattern

US Nationwide distribution.

device · product 92 of 94

PPM LOMBARD PRODUCTS R2A MEDIUM 10PLT, CATALOG M1065

Z-0874-2023
Recall number
Z-0874-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
20 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026320485, Batch Numbers: 1009527290

Distribution pattern

US Nationwide distribution.

device · product 93 of 94

PPM LOMBARD PRODUCTS IR&DB - TSA (32ML) 10PLT, CATALOG M1205-IR

Z-0875-2023
Recall number
Z-0875-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
12 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026320706, Batch Numbers: 1009497920

Distribution pattern

US Nationwide distribution.

device · product 94 of 94

PPM LOMBARD PRODUCTS T PHOSPHATE BUFFERSTERILE 20X9ML, CATALOG T8035

Z-0876-2023
Recall number
Z-0876-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Biomerieux Inc
Quantity
100 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
As the temperature and time out of range was exceeded, product performances cannot be guaranteed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Code information

UDI/DI 03573026321420, Batch Numbers: 1009564750

Distribution pattern

US Nationwide distribution.

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