Siemens Healthcare recalls Atellica IM Folate 140 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 Atellica IM Folate 140 test kits because they can produce negative bias when used with whole blood calibration. This means test results for folate in serum samples might be too low, potentially leading to incorrect health assessments.
The test kits can produce negative bias when whole blood calibration is used with serum samples. This means results may show lower folate levels than actually present, potentially causing incorrect health decisions.
People using Atellica IM Folate 140 test kits for in vitro folate testing in human serum or red blood cells. Those with medical conditions requiring accurate folate monitoring may be most affected.
Check for Siemens Material Number (SMN) 10995572 or lot numbers 15308337, 27949339, 41143343, 41144343, 62969345 and higher. The kits are sold for in vitro diagnostic use in folate testing.
Look for lot numbers 15308337, 27949339, 41143343, 41144343, 62969345 or higher on the test kit packaging.
The test kits can produce negative bias when whole blood calibration is used with serum samples, potentially leading to inaccurate folate results.
The recall notice does not specify a remedy. Check the lot number to see if it's affected and contact Siemens Healthcare for further guidance.
No, only kits with lot numbers 15308337, 27949339, 41143343, 41144343, 62969345 and higher are affected.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1149-2023 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1149-2023 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.
