Siemens Healthcare recalls Atellica IM BR 27.29 Assay 50 Test Kits due to calibration interval mismatch with instructions. All lots affected; users must follow specific steps to ensure accurate cancer antigen testing.
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 50 Test Kits because the calibration interval in the product does not match the instructions for use. This could lead to inaccurate cancer antigen testing results if not corrected.
The test kit's calibration interval is set to 10 days in the product but the instructions require it to be recalibrated every 3 days. This mismatch could cause inaccurate cancer antigen measurements if the kit is not recalibrated as specified.
Patients using the Atellica IM BR 27.29 Assay 50 Test Kit for cancer antigen CA 27.29 testing are affected. Healthcare providers and labs using this kit for in vitro diagnostics are most at risk.
Check for lot numbers 40476255, 64505255 (expiring 2021-08-03) or 89332257, 05694257 (expiring 2021-11-10). The kit is used for cancer antigen CA 27.29 testing with the Atellica IM Analyzer.
Verify if your kit's calibration interval matches the instructions for use (3 days instead of 10 days).
The test kit does not meet the Instructions for Use claimed calibration interval of 10 days; it should be recalibrated every 3 days.
Lot numbers 40476255, 64505257 (expiring 2021-08-03), 89332257, and 05694257 (expiring 2021-11-10).
No, but you must recalibrate the kit every 3 days as per the updated instructions to ensure accurate results.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2424-2021 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2424-2021 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.
