Siemens Healthcare recalls IMMULITE 1000 BR-MA (CA15-3) due to potential biotin interference in certain blood tests. Affected units have specific lot codes and may give inaccurate results if biotin levels are present.
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 IMMULITE 1000 BR-MA (CA15-3) blood analyzers because they may give inaccurate results when biotin is present in the patient's blood. This could lead to incorrect test results for certain blood tests.
The analyzers may produce inaccurate test results for specific blood tests if biotin is present in the patient's blood. Biotin is a common vitamin found in some foods and supplements, which can interfere with the test process.
People who own or use the IMMULITE 1000 BR-MA (CA15-3) blood analyzers with lot codes 0312 or 0313 are affected. Laboratory users and patients who rely on these tests are most at risk of inaccurate results.
Check the lot code on the device, which is either 0312 or 0313. The affected models are the IMMULITE 1000 BR-MA (CA15-3) blood analyzers.
Look for lot codes 0312 or 0313 on the device to confirm if it is affected.
The IMMULITE 1000 BR-MA (CA15-3) blood analyzers may give inaccurate results for certain blood tests if biotin is present in the patient's blood.
Check the lot code on the device; if it is 0312 or 0313, contact Siemens Healthcare for further instructions.
This recall is for potential inaccurate test results, not a safety hazard. The risk is low and does not involve physical 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-1677-2018 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1677-2018 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.
