Siemens Healthcare recalls ADVIA Chemistry Calibrator lots 534177 and 960742 due to calibration errors affecting bilirubin test accuracy. Affected users should contact Siemens for details.
Calibration errors have been observed with the Total and Direct Bilirubin assays when using Chemistry Calibrator lot 534177 for ADVIA Chemistry and lot 534179 for Atellica CH.
Siemens Healthcare is recalling specific lots of ADVIA Chemistry Calibrator devices because they can cause inaccurate bilirubin test results. This affects laboratory users who rely on these devices for blood testing. The issue could lead to incorrect medical diagnoses if not addressed.
The calibrator has been observed to produce calibration errors for Total and Direct Bilirubin assays. This means test results could be inaccurate, potentially leading to incorrect medical diagnoses if the device is used without correction.
Laboratory users who have the specific lots of ADVIA Chemistry Calibrator (534177 and 960742) are affected. Medical professionals using these devices for bilirubin testing are most at risk.
Check the lot number on your ADVIA Chemistry Calibrator. The affected lots are 534177 (sublots A, B, C) and 960742. The device may have a unique identifier (UDI) with the lot numbers listed.
Look for the lot number on your ADVIA Chemistry Calibrator device to determine if it is affected.
Lots 534177 (sublots A, B, and C) and 960742 are affected.
The device may produce inaccurate bilirubin test results, but the recall specifically states calibration errors have been observed with these lots.
Contact Siemens Healthcare directly for further instructions on how to handle the affected device.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2430-2020 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2430-2020 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.
