Siemens Healthcare recalls certain IMMULITE 2000/2000 XPi OM-MA (CA125) test kits due to potential biotin interference in specific 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 lots of IMMULITE 2000/2000 XPi OM-MA (CA125) test kits because they can give inaccurate results when biotin is present in blood samples. This could lead to incorrect test results for certain cancer markers and other health indicators.
The test kits may produce inaccurate results if biotin is present in the blood sample. Biotin is a common vitamin found in some foods and supplements, and the current instructions don't list the biotin concentration that could interfere with the test results.
People who use the recalled IMMULITE 2000/2000 XPi OM-MA (CA125) test kits for blood tests, particularly those checking for cancer markers like CA125. Individuals with high biotin levels in their blood may be at slightly higher risk of inaccurate results.
Check the lot code on the test kit packaging. Affected lots have the code 'CA125' with specific numbers: 287, 289, or 290. The test kits are for blood tests that measure cancer markers like CA125.
Look for the lot code 'CA125' with numbers 287, 289, or 290 on the test kit packaging.
The test kits may give inaccurate results if biotin is present in blood samples, as the current instructions don't list the biotin concentration that could interfere.
Check the lot code on the packaging. If it's 'CA125' with numbers 287, 289, or 290, you may need to contact Siemens Healthcare for further instructions.
No, this is a low-risk issue that could lead to inaccurate test results, not physical harm 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-1683-2018 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1683-2018 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.
