Siemens Healthcare recalls Centaur Folate 500 test kits with negative bias when using whole blood calibration for serum samples. Affected lots may give inaccurate folate results.
Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.
Siemens Healthcare is recalling Centaur Folate 500 test kits that can produce negative bias when used with whole blood calibration for serum samples. This could lead to inaccurate folate test results, potentially affecting medical decisions.
The test kit shows negative bias when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) is used to test serum samples. This means results may be too low, potentially leading to incorrect medical conclusions about folate levels.
People using the Centaur Folate 500 test kit for folate testing in blood samples. Those who have the affected lot numbers are most at risk of inaccurate results.
Check the lot numbers on the test kit: 16277336, 23278336, 25958336, 63092344 and higher. The test kit is for in vitro diagnostic use in folate testing of human serum and red blood cells.
Look for lot numbers 16277336, 23278336, 25958336, or 63092344 and higher on the test kit.
The test kit can show negative bias when whole blood calibration is used to test serum samples, which may lead to inaccurate folate results.
Check the lot number on the test kit. If it's 16277336, 23278336, 25958336, or 63092344 and higher, it's affected. Siemens Healthcare will update the Instructions for Use to address the issue.
No. The hazard is limited to 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-1154-2023 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1154-2023 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.
