Siemens Healthcare recalls specific IMMULITE 2000/2000 XPi BR-MA (CA15-3) test kits due to potential biotin interference in certain assays. 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 2000/2000 XPi BR-MA (CA15-3) test kits because they may give inaccurate results when biotin is present in samples. This could lead to incorrect test outcomes for certain health conditions.
The test kits may produce inaccurate results when biotin is present in the sample. Biotin is a common vitamin found in some foods, supplements, and medications. This interference can lead to incorrect test outcomes for specific health conditions.
Lab users who operate the IMMULITE 2000/2000 XPi systems with the affected lot numbers (265-267) are most at risk. Patients using these tests may receive inaccurate results if biotin is present in their samples.
Check the lot number on the test kit packaging. Affected lots are 265, 266, and 267 for the IMMULITE 2000/2000 XPi BR-MA (CA15-3) system.
Look for the lot number on the test kit packaging; affected lots are 265, 266, and 267.
The test kits may produce inaccurate results when biotin is present in the sample, which can lead to incorrect test outcomes for certain health conditions.
Check the lot number on the test kit packaging. If it's 265, 266, or 267, contact Siemens Healthcare for further instructions.
No, this recall involves potential inaccurate test results, not a physical hazard that could cause 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-1691-2018 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1691-2018 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.
