Siemens Healthcare recalls Atellica IM BR 27.29 Assay 250 Test Kit due to incorrect calibration interval in instructions. The kit may give inaccurate results if used beyond 3 days.
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. Using these kits beyond the 3-day calibration window could lead to inaccurate cancer antigen CA 27.29 test results.
The test kit's instructions claim a 10-day calibration interval, but the actual calibration should be done every 3 days. If the kit is used beyond 3 days without recalibration, it may produce inaccurate cancer antigen CA 27.29 test results.
People who own or use Atellica IM BR 27.29 Assay 250 Test Kits for cancer antigen CA 27.29 testing. Those who have the kit with lot numbers 41331255, 74682255, or 91605257 are most at risk.
Check the lot number on the kit: 41331255, 74682255, or 91605257. The kit expires by August 3, 2021, or November 10, 2021, depending on the lot.
Look for lot numbers 41331255, 74682255, or 91605257 on the test kit packaging.
The test kit's instructions incorrectly state a 10-day calibration interval instead of the required 3-day interval, which could lead to inaccurate cancer antigen CA 27.29 test results.
Check the lot number on the kit. If it matches 41331255, 74682255, or 91605257, contact Siemens Healthcare for further instructions.
The recall notice does not specify a deadline for action.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2426-2021 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2426-2021 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.
