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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79505

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

Open FDA event record

Event summary

Timeline bucket
January 02, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Siemens Healthcare Diagnostics, 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

24 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 24

Dimension¿ Thyroid Stimulating Hormone (TSHL) Flex¿ reagent cartridge

Z-1668-2018
Recall number
Z-1668-2018
Initiated
January 02, 2018
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine, and ADVIA Centaur DHEAS, incorrectly state the level at which biotin does not interfere.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine, and ADVIA Centaur DHEAS, incorrectly state the level at which biotin does not interfere.

Code information

TSHL, radioimmunoassay, thyroid-stimulating hormone, RF612, SMN# 10464524 Lot codes: EB7276 EC7298 EA7318 EB7346 EC7346 EA8012 EA8033 EA8051 EC8080 EB8107 EB8121 EA8143 EB8143 EA8177 EB8177 EB8199 EA8223 EA8241 EA8261

Distribution pattern

Nationwide and Canada, Mexico, and Thailand

device · product 2 of 24

Dimension¿ Free Thyroxine (FT4L) Flex¿ reagent cartridge

Z-1669-2018
Recall number
Z-1669-2018
Initiated
January 02, 2018
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine, and ADVIA Centaur DHEAS, incorrectly state the level at which biotin does not interfere.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine, and ADVIA Centaur DHEAS, incorrectly state the level at which biotin does not interfere.

Code information

FT4L, radioimmunoassay, free thyroxime, RF610, SMN# 10464523 Lot codes: EA7276 EC7304 EC7333 EA7346 EB8010 EA8037 EA8065 EB8086 EB8108 EA8130 EA8156 EA8179 EA8205 EA8233 FD8254

Distribution pattern

Nationwide and Canada, Mexico, and Thailand

device · product 3 of 24

Dimension¿ Sirolimus (SIRO) Flex¿ reagent cartridge

Z-1670-2018
Recall number
Z-1670-2018
Initiated
January 02, 2018
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.

Code information

SIRO, sirolimus test system, DF306, SMN# 10464331 Lot codes: BB7336 FA8037 FA8081 BB8167 FB8177 FB8219

Distribution pattern

Nationwide and Canada, Mexico, and Thailand

device · product 4 of 24

Dimension Vista¿ Cardiac Troponin I (CTNI) Flex¿ reagent cartridge

Z-1671-2018
Recall number
Z-1671-2018
Initiated
January 02, 2018
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.

Code information

CTNI, immunoassay method, troponin subunit, K6421, SMN# 10445098 Lot codes: 16336BA 16347BD 16363BC 17032AD 17045BC 17054BD 17074BC 17093BD 17121BA 17145BE 17180BB 17193BD 17201BB 17223BA 17264BC

Distribution pattern

Nationwide and Canada, Mexico, and Thailand

device · product 5 of 24

Dimension Vista¿ Mass Creatine Kinase (MMB) Flex¿ reagent cartridge

Z-1672-2018
Recall number
Z-1672-2018
Initiated
January 02, 2018
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.

Code information

MMB, colorimetric method, cpk or isozymes, K6420, SMN# 10445097 Lot codes: 16284BD 16312BB 17011BD 17058BD 17093BC 17136BE 17186BE 17235BC 17268BA

Distribution pattern

Nationwide and Canada, Mexico, and Thailand

device · product 6 of 24

Dimension Vista¿ Thyroid Stimulating Hormone (TSH) Flex¿ reagent cartridge

Z-1673-2018
Recall number
Z-1673-2018
Initiated
January 02, 2018
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine, and ADVIA Centaur DHEAS, incorrectly state the level at which biotin does not interfere.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine, and ADVIA Centaur DHEAS, incorrectly state the level at which biotin does not interfere.

Code information

TSH, radioimmunoassay, thyroid stimulating hormone, RF612, SMN# 10464524 Lot codes: 16277BD 16322BB 17005BB 17023AC 17069AA 17093BB 17122AA 17150AA 17193BA 17215AC 17268AA

Distribution pattern

Nationwide and Canada, Mexico, and Thailand

device · product 7 of 24

IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi 3g Allergy specific IgE Universal Kit

Z-1674-2018
Recall number
Z-1674-2018
Initiated
January 02, 2018
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.

Code information

3g Allergy specific IgE Universal kit, 3g Allergy specific IgE Universal kit (IMMULITE 2000/IMMULITE 2000 XPi L2KUN6 (D)) Lot codes: 3g Allergy Specific IgE Lot # 461 462 463 464 465 466 467 468 469 470 471 472 473 475 476 3g Allergy Specific IgE Lot # D463 D464 D465 D466 D467 D469 D471 D472 D476 D483

Distribution pattern

Nationwide and Canada, Mexico, and Thailand

device · product 8 of 24

IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Anti HBc

Z-1675-2018
Recall number
Z-1675-2018
Initiated
January 02, 2018
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.

Code information

Anti HBc, Anti HBc (IMMULITE 2000/IMMULITE 2000 XPi L2KHC2 (D)) Lot codes: Anti HBcM # 579 580 581 D579 D580 D581 ***Added 9/11/20*** D602

Distribution pattern

Nationwide and Canada, Mexico, and Thailand

device · product 9 of 24

IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Folic Acid

Z-1676-2018
Recall number
Z-1676-2018
Initiated
January 02, 2018
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.

Code information

Folic Acid, Folic Acid (IMMULITE 2000/IMMULITE 2000 XPi L2KFO2, L2KFO6) Lot codes: Folic Acid Lot # 502 503 504 505 506 508 514

Distribution pattern

Nationwide and Canada, Mexico, and Thailand

device · product 10 of 24

IMMULITE ¿ /IMMULITE ¿ 1000 BR-MA (CA15-3)

Z-1677-2018
Recall number
Z-1677-2018
Initiated
January 02, 2018
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.

Code information

BR-MA/CA15-3, BR-MA/CA15-3 (IMMULITE/IMMULITE 1000, LKBR1), (IMMULITE 2000/IMMULITE 2000 XPi, LKBR2) Lot codes: 0312 0313

Distribution pattern

Nationwide and Canada, Mexico, and Thailand

device · product 11 of 24

IMMULITE ¿ /IMMULITE ¿ 1000 CEA

Z-1678-2018
Recall number
Z-1678-2018
Initiated
January 02, 2018
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.

Code information

CEA, CEA (IMMULITE/IMMULITE 1000, LKCE1), (IMMULITE 2000/IMMULITE 2000 XPi, LKCE2, LKCE6) Lot codes: 0355 0356 0357

Distribution pattern

Nationwide and Canada, Mexico, and Thailand

device · product 12 of 24

IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi CEA

Z-1679-2018
Recall number
Z-1679-2018
Initiated
January 02, 2018
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.

Code information

CEA, CEA (IMMULITE/IMMULITE 1000, LKCE1), (IMMULITE 2000/IMMULITE 2000 XPi, LKCE2, LKCE6) Lot codes: 0355 0356 0357 CEA Lot # 200 tests 311 312 313

Distribution pattern

Nationwide and Canada, Mexico, and Thailand

device · product 13 of 24

IMMULITE ¿ /IMMULITE 1000 ¿ Gastrin

Z-1680-2018
Recall number
Z-1680-2018
Initiated
January 02, 2018
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.

Code information

Gastrin, Gastrin (IMMULITE/IMMULITE 1000, LKGA1), (IMMULITE 2000/IMMULITE 2000 XPi, LKGA2) Lot codes: Gastrin Lot # 0345 0346 0347

Distribution pattern

Nationwide and Canada, Mexico, and Thailand

device · product 14 of 24

IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Gastrin

Z-1681-2018
Recall number
Z-1681-2018
Initiated
January 02, 2018
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.

Code information

Gastrin, Gastrin (IMMULITE/IMMULITE 1000, LKGA1), (IMMULITE 2000/IMMULITE 2000 XPi, LKGA2) Lot codes: 251 252 253 254 255

Distribution pattern

Nationwide and Canada, Mexico, and Thailand

device · product 15 of 24

IMMULITE ¿ /IMMULITE ¿ 1000 OM-MA (CA125)

Z-1682-2018
Recall number
Z-1682-2018
Initiated
January 02, 2018
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.

Code information

OM-MA (CA125), OM-MA (CA125) (IMMULITE/IMMULITE 1000, LKOP1), (IMMULITE 2000/IMMULITE 2000 XPi, LKOP2) Lot codes: CA125 (OM-MA) 0211 0212 0213

Distribution pattern

Nationwide and Canada, Mexico, and Thailand

device · product 16 of 24

IMMULITE 2000/IMMULITE ¿ 2000 XPi OM-MA (CA125)

Z-1683-2018
Recall number
Z-1683-2018
Initiated
January 02, 2018
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.

Code information

OM-MA (CA125), OM-MA (CA125) (IMMULITE/IMMULITE 1000, LKOP1), (IMMULITE 2000/IMMULITE 2000 XPi, LKOP2) Lot codes: CA125 (OM-MA) 287 289 290

Distribution pattern

Nationwide and Canada, Mexico, and Thailand

device · product 17 of 24

IMMULITE ¿ /IMMULITE ¿ 1000 TG

Z-1684-2018
Recall number
Z-1684-2018
Initiated
January 02, 2018
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.

Code information

TG, TG (IMMULITE/IMMULITE 1000, LKTY1(D)), (IMMULITE 2000/IMMULITE 2000 XPi, LKTY2(D)) Lot codes: 0289 0290 0291 D0289 D0290 D0291

Distribution pattern

Nationwide and Canada, Mexico, and Thailand

device · product 18 of 24

IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi TG

Z-1685-2018
Recall number
Z-1685-2018
Initiated
January 02, 2018
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.

Code information

TG, TG (IMMULITE/IMMULITE 1000, LKTY1(D)), (IMMULITE 2000/IMMULITE 2000 XPi, LKTY2(D)) Lot codes: TG Lot # 346 347 348 349 350 351 352 353 354 355 356 D348 D349 D350 D351 D352 D353 D354 D356

Distribution pattern

Nationwide and Canada, Mexico, and Thailand

device · product 19 of 24

IMMULITE ¿ /IMMULITE ¿ 1000 Vitamin B12

Z-1686-2018
Recall number
Z-1686-2018
Initiated
January 02, 2018
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.

Code information

Vitamin B12, Vitamin B12 (IMMULITE/IMMULITE 1000, LKVB1) Lot codes: 0338 0339 0340 0341

Distribution pattern

Nationwide and Canada, Mexico, and Thailand

device · product 20 of 24

ADVIA Centaur¿ Cyclosporine

Z-1687-2018
Recall number
Z-1687-2018
Initiated
January 02, 2018
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine, and ADVIA Centaur DHEAS, incorrectly state the level at which biotin does not interfere

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine, and ADVIA Centaur DHEAS, incorrectly state the level at which biotin does not interfere

Code information

ADVIA Centaur¿ Cyclosporine; Cyclosporine; SMN 10335448 Lot codes: ADVIA Centaur CSA Lot # 38182025 64432025 98554025 58299030 25547030 30153031 77934031 97170031

Distribution pattern

Nationwide and Canada, Mexico, and Thailand

device · product 21 of 24

ADVIA Centaur¿ DHEA-SO4

Z-1688-2018
Recall number
Z-1688-2018
Initiated
January 02, 2018
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine, and ADVIA Centaur DHEAS, incorrectly state the level at which biotin does not interfere

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine, and ADVIA Centaur DHEAS, incorrectly state the level at which biotin does not interfere

Code information

ADVIA Centaur¿ DHEA-SO4; radioimmunoassay, dehydroepiandrosterone (free and sulfate); SMN 10282227 ADVIA Centaur DHEA-S Kit Lot # 00119053 14041053 80449053 90520053 29750054 30423054 39155054 50533054 63267055 68936055 79273055 86427055 06402057 07109057 14187057 37499057

Distribution pattern

Nationwide and Canada, Mexico, and Thailand

device · product 22 of 24

ADVIA Centaur¿ Folate (FOL)

Z-1689-2018
Recall number
Z-1689-2018
Initiated
January 02, 2018
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.

Code information

ADVIA Centaur¿ Folate; acid, folic, radioimmunoassay; SMN 10310308; 10325366; 10331250 Lot codes: ADVIA Centaur Folate (REF) Lot # 03460256 09302256 81236256 09294257 30152258 ADVIA Centaur Folate (100 Test) Lot # 76793256 85114256 96368256 05299257 99361257 19045258 25443258 40856260 ADVIA Centaur Folate (500 test) Lot # 73249256 76207256 85113256 00245257 00495257 03779257 05298257 99360257 19042258 19043258 19044258 31130258 36171260

Distribution pattern

Nationwide and Canada, Mexico, and Thailand

device · product 23 of 24

ADVIA Centaur¿ HBc IgM

Z-1690-2018
Recall number
Z-1690-2018
Initiated
January 02, 2018
Classification
Class II
Status
Terminated
Quantity
6

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.

Code information

ADVIA Centaur¿ HBc IgM; test, hepatitis b (b core, be antigen, be antibody, b core igm); SMN 10308978 Lot codes: ADVIA Centaur aHBcM Lot # 02437164 14331164 20876164 29394164 81764164 93146164 26976167 39604167 44125167 56754167 67635167 77328167 01396170 07110170 21484170 67103170 86117170 92364170 31751171 33726171 41538171 ***Added 9/11/20*** 10308978 ***Added 11/2/20*** 62572190 ***Added 3/11/21*** 39927194

Distribution pattern

Nationwide and Canada, Mexico, and Thailand

device · product 24 of 24

IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi BR-MA (CA15-3)

Z-1691-2018
Recall number
Z-1691-2018
Initiated
January 02, 2018
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.

Code information

BR-MA/CA15-3, BR-MA/CA15-3 (IMMULITE/IMMULITE 1000, LKBR1), (IMMULITE 2000/IMMULITE 2000 XPi, LKBR2) CA15-3(BR-MA) Lot # 265 266 267

Distribution pattern

Nationwide and Canada, Mexico, and Thailand

Field note

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