Siemens Healthcare recalls Atellica IM BR 27.29 Assay 250 Test Kits due to incorrect calibration interval in instructions. Kits may give inaccurate cancer antigen CA 27.29 results if used beyond 3-day calibration.
Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. IFU calibration updated interval from 10 days to 3 days for all current and future kit lot numbers
Siemens Healthcare is recalling Atellica IM BR 27.29 Assay 250 Test Kits because the calibration interval in the instructions was incorrectly set to 10 days instead of 3 days. This could lead to inaccurate cancer antigen CA 27.29 test results if the kit is used beyond the proper calibration period.
The test kit's instructions claim a 10-day calibration interval, but the actual calibration should be done every 3 days. Using the kit beyond this interval without recalibration can cause inaccurate cancer antigen CA 27.29 test results.
People using Atellica IM BR 27.29 Assay 250 Test Kits for cancer antigen CA 27.29 testing in human serum and plasma. Those who have the specific lot numbers listed are most at risk of inaccurate results.
Check for lot numbers 48553255, 78009255, or 90311257 with expiration dates 2021-08-03 or 2021-11-10. The kit is used for cancer antigen CA 27.29 testing in human serum and plasma.
Look for lot numbers 48553255, 78009255, or 90311257 on the kit packaging.
The recall is because the calibration interval in the instructions was incorrectly set to 10 days instead of 3 days, which could lead to inaccurate cancer antigen CA 27.29 test results.
The official notice does not specify a remedy or action for affected kits.
Check for lot numbers 48553255, 78009255, or 90311257 with expiration dates 2021-08-03 or 2021-11-10.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2425-2021 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2425-2021 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.
