Siemens Healthcare recalls ADVIA Centaur HBc IgM tests due to potential biotin interference in certain blood tests. Affected units may give inaccurate results if biotin levels are present in samples.
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.
Siemens Healthcare is recalling ADVIA Centaur HBc IgM tests because they can give inaccurate results when biotin is present in blood samples. This interference affects specific tests for hepatitis B and other markers.
The tests can produce inaccurate results if biotin is present in the blood sample. Biotin is a vitamin that some people take in supplements or through diet. The interference occurs because the test design doesn't account for biotin levels in certain assays.
Users of ADVIA Centaur HBc IgM tests who perform blood tests for hepatitis B, and individuals using these tests for other markers like folic acid or vitamin B12. Those with high biotin levels in their blood may be at slightly higher risk.
Check for the ADVIA Centaur HBc IgM test name on the label. Lot numbers include 02437164, 14331164, 20876164, 29394164, 81764164, 93146164, 26976167, 39604167, 44125167, 56754167, 67635167, 77328167, 01396170, 07110170, 21484170, 67103170, 86117170, 92364170, 31751171, 33726171, 41538171, 10308978, 62572190, 39927194.
Look for the ADVIA Centaur HBc IgM test name and lot numbers listed in the recall notice.
The tests can give inaccurate results if biotin is present in blood samples, which can happen with certain supplements or foods.
Check the test label for the lot numbers listed in the recall notice. If you have the affected lot numbers, contact Siemens Healthcare for guidance.
This is a low-risk issue that could lead to inaccurate test results, not a physical safety hazard like fire or injury.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1690-2018 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1690-2018 from Siemens Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
