Siemens Healthcare recalls Atellica CH Chemistry Calibrators with specific lot numbers due to calibration errors affecting bilirubin test accuracy. Affected units may provide incorrect bilirubin results.
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 Atellica CH Chemistry Calibrators with certain lot numbers because they can cause inaccurate bilirubin test results. This means lab tests for bilirubin might be wrong, which could lead to incorrect medical diagnoses.
The calibrator may produce incorrect bilirubin test results when used with specific lot numbers. This error could lead to inaccurate medical diagnoses if the device is used in laboratory settings.
Lab users who have the Atellica CH Chemistry Calibrator with lot numbers 534179 or 911591 are affected. Healthcare professionals using these devices for bilirubin testing are most at risk.
Check the lot number on the device: 534179 (sublots A-E) or 911591 (sublots A-C). The device may also have a unique identifier code starting with (01)00630414597492(10).
Look for the lot number on the device: 534179 (sublots A-E) or 911591 (sublots A-C).
Lot numbers 534179 (sublots A-E) and 911591 (sublots A-C) are affected.
Check the lot number on the device: 534179 (sublots A-E) or 911591 (sublots A-C). The device may also have a unique identifier code starting with (01)00630414597492(10).
The recall record does not specify a remedy, so no action is required beyond checking if your device is affected.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2431-2020 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2431-2020 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.
