Exact FDA event identifier

Event 80813

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

Event summary

Timeline bucket: August 13, 2018
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Remel 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

3 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 3

remel THIOGLYCOLLATE MEDIUM W/O IND. W/ DEXTROSE W/ HEMIN & VIT.K (a) 10ML, REF 07182 (b) 10ML, REF 07180 (c) 5ML, REF 064732 (d) 5ML, REF 064730 (e) 9ML, REF 064720

Z-3017-2018

Recall number: Z-3017-2018
Initiated: August 13, 2018
Classification: Class II
Status: Terminated
Recalling firm: Remel Inc
Quantity: 2730 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms.

Code information

(a) 10ML, REF 07182, Lot numbers: 258907, 260413, 258908, 260519 (b) 10ML, REF 07180, Lot numbers: 259526, 258906, 258903, 258904, 258905 (c) 5ML, REF 064732, Lot numbers: 271667, 258182, 259521 (d) 5ML, REF 064730, Lot numbers: 254755, 272020, 260509, 258181, 273564, 258627, 271476, 258629, 271665, 259507, 251146, 272499 (e) 9ML, REF 064720, Lot numbers: 254749, 272497, 251145, 272015, 258183, 258626, 271479, 258625

Distribution pattern

US, Canada, Singapore

device · product 2 of 3

remel THIOGLYCOLLATE MEDIUM W/O INDICATOR. W/ DEXTROSE (a) 9ML, REF 064700 (b) 10ML, REF 07176 (c) 9ML, REF 064702

Z-3018-2018

Recall number: Z-3018-2018
Initiated: August 13, 2018
Classification: Class II
Status: Terminated
Recalling firm: Remel Inc
Quantity: 384 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms.

Code information

(a) 9ML, REF 064700, Lot numbers: 254751, 259508, 272498 (b) 10ML, REF 07176, Lot numbers: 259521 (c) 9ML, REF 064702, Lot numbers: 274247

Distribution pattern

US, Canada, Singapore

device · product 3 of 3

remel THIOGLYCOLLATE MEDIUM, REF 05152

Z-3019-2018

Recall number: Z-3019-2018
Initiated: August 13, 2018
Classification: Class II
Status: Terminated
Recalling firm: Remel Inc
Quantity: 48 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms.

Code information

Lot number: 258192

Distribution pattern

US, Canada, Singapore