Siemens Healthcare recalls Atellica CH Toxicology Calibrators due to positive bias in salicylate assays. Affected units have specific Siemens Material Numbers and expiration dates. 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 Atellica CH Toxicology Calibrators (TOX CAL) because they may cause positive bias in salicylate assays. This means test results could be inaccurate, potentially leading to incorrect medical diagnoses.
The calibrators may produce positive bias in salicylate assays, meaning test results could be higher than actual levels. This could lead to incorrect medical diagnoses if the calibrators are used without correction.
Healthcare labs using the Atellica CH Toxicology Calibrators for in vitro diagnostics are affected. Lab technicians and medical professionals who use these calibrators for salicylate testing are most at risk.
Check for Siemens Material Number (SMN) 11099440, UDi-DI 00630414597614, and lot numbers 74285306 (exp. 2023-05-31), 74536672 (exp. 2024-03-31), or 74732386 (exp. 2024-11-30).
Reach out to Siemens Healthcare for specific instructions on how to handle affected units.
The calibrators may produce test results that are higher than actual salicylate levels, potentially leading to incorrect medical diagnoses.
Units with Siemens Material Number 11099440, UDi-DI 00630414597614, and lot numbers 74285306 (exp. 2023-05-31), 74536672 (exp. 2024-03-31), or 74732386 (exp. 2024-11-30).
No, but you should contact Siemens Healthcare for specific instructions on handling affected units.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1632-2023 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1632-2023 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.
