Siemens Healthcare recalls IMMULITE 1000 OM-MA (CA125) kits due to potential biotin interference in certain tests. Affected lots may give inaccurate results if biotin is 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 1000 OM-MA (CA125) test kits because they can give inaccurate results when biotin is present in patient samples. This could lead to incorrect test outcomes for certain health conditions.
The test kits may produce incorrect results if biotin is present in patient samples. Biotin is a common vitamin found in some foods and supplements. This interference could lead to false positive or negative test results for certain health markers.
People using the recalled IMMULITE 1000 OM-MA (CA125) test kits for specific blood tests may be affected. Those with biotin supplements or in biotin-rich foods could experience inaccurate results.
Check the lot code on the test kit packaging. Affected lots have codes 0211, 0212, or 0213 for the IMMULITE 1000 OM-MA (CA125) test.
Look for lot codes 0211, 0212, or 0213 on the IMMULITE 1000 OM-MA (CA125) test kit packaging.
The test kits may give inaccurate results if biotin is present in patient samples, which could lead to false positive or negative test results for certain health markers.
Check the lot code on the test kit packaging. If it's 0211, 0212, or 0213, stop using it and contact Siemens Healthcare for instructions.
No, the recall is for potential inaccurate test results, not a physical safety hazard. The risk is low and does not involve 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-1682-2018 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1682-2018 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
