FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc.: ADVIA Centaur HBc IgM
- Recall number
- Z-1690-2018
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product
- ADVIA Centaur HBc IgM
- Status
- Terminated
- Initiated
- 2018-01-02
- Posted
- 2018-05-04
- Terminated
- 2023-02-10
- Reason
- 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.
- Root cause
- Error in labeling
- Action
- Siemens Healthcare Diagnostics issued a recall in March 2017 for products with incorrect units for biotin in the Instructions for Use. After further investigation, recalling firm determined that more Siemens products also had missing or incorrect information in the IFUs for which two recalls were initiated, and Amended Corrections and Removals Reports were submitted to the FDA
- Quantity
- 6
- Distribution
- Nationwide and Canada, Mexico, and Thailand
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- ["P030040"]
- Product code
- LOM
- Firm FEI
- 2432235
- Firm city
- Tarrytown
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28