Siemens Healthcare recalls ADVIA Centaur Folate 100 test kits due to negative bias when used with certain blood samples. Affected kits may give inaccurate folate results. Contact for remedy details.
Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.
Siemens Healthcare is recalling ADVIA Centaur Folate 100 test kits because they can produce negative bias when used with whole blood calibration. This means the test might show lower folate levels than actual in serum samples, potentially leading to incorrect health assessments.
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 the results may indicate lower folate levels than actually present, potentially causing incorrect health decisions.
Individuals using the ADVIA Centaur Folate 100 test kit for folate testing in human serum or red blood cells. Lab users and healthcare providers are most at risk of inaccurate results.
Check for Siemens Material Number (SMN) 10310308 or lot numbers 16275336, 21333336, 22318336, 23066336, 27947338, 62967344 and higher. The kit is for in vitro diagnostic use in folate testing.
Look for lot numbers 16275336, 21333336, 22318336, 23066336, 27947338, or 62967344 and higher on the test kit packaging.
Reach out to Siemens Healthcare for instructions on how to handle affected kits, as the recall affects all current and future lots until the Instructions for Use are updated.
The test kit can produce negative bias when used with whole blood calibration for serum samples, potentially leading to inaccurate folate results.
Lot numbers 16275336, 21333336, 22318336, 23066336, 27947338, 62967344 and higher are affected.
If you use the ADVIA Centaur Folate 100 test kit for folate testing, you may get inaccurate results that could impact health decisions.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1152-2023 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1152-2023 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.
