Siemens Healthcare recalls ADVIA Centaur Folate tests due to potential biotin interference in certain blood tests. Affected lots may give inaccurate results if biotin is present in the patient's blood.
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 ADVIA Centaur Folate blood tests because they can give inaccurate results when biotin is present in a patient's blood. This interference could lead to incorrect test results for certain blood tests.
The tests can be affected by biotin in the patient's blood, which may cause inaccurate results for certain blood tests. This interference occurs because the tests are not properly designed to account for biotin levels.
People who use ADVIA Centaur Folate blood tests for the listed assays may be affected. Those with high biotin levels in their blood are at slightly higher risk of inaccurate results.
Check the lot number on the test kit. Affected lots include specific numbers listed in the recall notice, such as 03460256, 09302256, and others.
Look for the lot number on the test kit, which is listed in the recall notice.
The tests can give inaccurate results if biotin is present in the patient's blood, which may lead to incorrect test results for certain blood tests.
Check the lot number on the test kit. If it matches the listed affected lots, contact Siemens Healthcare for further instructions.
No, this is a low-risk issue that could cause inaccurate test results, not physical harm.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1689-2018 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1689-2018 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.
