Siemens Healthcare recalls IMMULITE 2000/2000 XPi Anti HBc tests due to potential biotin interference in certain blood tests. Affected lots 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 specific IMMULITE 2000/2000 XPi Anti HBc blood tests because they can give inaccurate results if biotin is present in the blood sample. This interference could lead to incorrect test outcomes for certain health conditions.
The tests can be affected by biotin in the blood sample. Biotin is a vitamin that some people take in supplements or through diet. If the test is run when biotin is present, it might give wrong results for certain health markers.
People who use these specific blood tests for certain health screenings may be affected. Those with high biotin levels in their blood could see inaccurate results.
Check the lot code on the test kit: 579, 580, 581, D579, D580, D581, or D602. These are the specific lots affected by the recall.
Look for the lot code on the test kit: 579, 580, 581, D579, D580, D581, or D602.
The tests can give inaccurate results if biotin is present in the blood sample, which may happen in people who take biotin supplements or consume biotin-rich foods.
Check the lot code on the test kit. If it matches the affected lots listed, you may need to use a different test or contact Siemens Healthcare for guidance.
No, the recall is for potential inaccurate results, not physical harm. The risk is low and only affects test accuracy.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1675-2018 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1675-2018 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.
