Siemens recalls Atellica IM Folate 700 test kits for negative bias when testing serum samples, affecting lots 16097337, 44861343, 63869345 and higher. Users should check their kit's lot number and contact Siemens for updates.
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 due to negative bias when used with whole blood calibration for serum samples. This could lead to inaccurate folate measurements, which may affect medical decisions.
The test kit shows negative bias when whole blood calibration is used on serum samples. This means results may be too low, potentially leading to incorrect medical decisions about folate levels.
Individuals using Atellica IM Folate 700 test kits for folate testing in human serum or red blood cells. Those with medical conditions requiring precise folate monitoring are most at risk.
Check the lot number on the test kit: 16097337, 44861343, 63869345, or higher. The kit is labeled for in vitro diagnostic use in folate testing.
Look for lot numbers 16097337, 44861343, 63869345, or higher on the test kit.
Reach out to Siemens Healthcare to confirm if your kit needs correction or if the Instructions for Use have been updated.
The test kit shows negative bias when whole blood calibration is used on serum samples, which could lead to inaccurate folate measurements.
Lot numbers 16097337, 44861343, 63869345 and higher are affected.
No, but you should check the lot number and contact Siemens for updates if you have the affected lot numbers.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1151-2023 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1151-2023 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.
