Siemens Healthcare recalls ADVIA Centaur Folate 500 test kits due to negative bias when testing serum samples. Affected kits may give inaccurate folate results. No remedy specified in recall notice.
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 500 test kits that may give inaccurate folate results when used with certain blood samples. This could lead to incorrect health assessments for folate levels.
The test kit shows negative bias when whole blood calibration is used with serum samples. This means the results may be too low, potentially leading to incorrect health assessments for folate levels.
People using the ADVIA Centaur Folate 500 test kit for in vitro diagnostics may be affected. Those testing serum samples with the kit could get inaccurate folate results.
Check for Siemens Material Number (SMN) 10325366 or lot numbers 16276336 through 62966344. The recall affects all current and future lots until the Instructions for Use are updated.
Look for lot numbers 16276336, 21334336, 22079336, 27946338, 41225342, or 62966344 on the test kit packaging.
The test kit shows negative bias when whole blood calibration is used with serum samples, which could lead to inaccurate folate results.
Negative bias means the test results may be too low, potentially leading to incorrect health assessments for folate levels.
Check for Siemens Material Number (SMN) 10325366 or lot numbers 16276336 through 62966344 on the test kit packaging.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1153-2023 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1153-2023 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.
