Siemens Healthcare recalls ADVIA ToxAmmonia Calibrators due to positive bias in ethanol and ammonia tests. Affected units have specific lot numbers and material codes. Consumers should contact Siemens for details.
Reassignment of the Atellica CH Toxicology Calibrators (TOX CAL) and ADVIA Chemistry ToxAmmonia Calibrators for the Atellica CH Salicylate (Sal) Assay due to a positive bias
Siemens Healthcare is recalling ADVIA ToxAmmonia Calibrators used in ethanol and ammonia tests because they may show falsely high results. This could lead to incorrect test outcomes if the calibrators are not properly adjusted.
The calibrators may show positive bias, meaning they produce falsely high results for ethanol and ammonia tests. This could cause inaccurate test results if the calibrators are not properly adjusted. The risk is low because the issue affects calibration accuracy rather than causing immediate harm.
Healthcare labs using Siemens ADVIA Chemistry systems with the recalled calibrators for ethanol and ammonia tests. Lab technicians handling these specific calibrators are most at risk.
Check for Siemens Material Number (SMN) 10309217 or UDI-DI 00630414479286. Lot numbers 9520531 (expiring May 2023) or 9520341 (expiring March 2024) indicate affected units.
Look for Siemens Material Number (SMN) 10309217 or UDI-DI 00630414479286 on the calibrator.
The calibrator may show positive bias, causing falsely high results for ethanol and ammonia tests. This could lead to inaccurate test outcomes if not properly adjusted.
Contact Siemens Healthcare directly for specific instructions on how to handle the recalled calibrator.
The recall addresses potential inaccurate test results, not immediate safety risks. The danger level is low_risk.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1631-2023 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1631-2023 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.
