Siemens Healthcare recalls Atellica IM Folate 700 test kits for in vitro diagnostics due to negative bias when testing 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 Atellica IM Folate 700 test kits because they can produce negative bias when used to test serum samples. This means the test might show lower folate levels than actually present, potentially leading to incorrect health assessments.
The test kit shows negative bias when whole blood calibration is used on serum samples. This means the results may indicate lower folate levels than actually present, which could lead to incorrect health decisions.
People using the Atellica IM Folate 700 test kit for in vitro diagnostics, particularly those testing serum samples for folate levels. Those with medical conditions requiring accurate folate monitoring may be most at risk.
Check for the Siemens Material Number (SMN) 10995573 and lot numbers 15307337, 27948339, 41142343, or 62968345 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 15307337, 27948339, 41142343, or 62968345 and higher on the test kit packaging.
The test kit shows negative bias when whole blood calibration is used on serum samples, which can lead to inaccurate folate results.
The official recall notice does not specify a remedy, so you should check with Siemens Healthcare for further instructions.
The recall is for inaccurate test results, not a physical hazard, so there is no risk of serious 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-1150-2023 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1150-2023 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.
