Siemens Atellica CH Toxicology Calibrator Recall: Positive Bias Risk
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.
Lower-risk recall
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
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/58613-siemens-atellica-ch-toxicology-calibrator-recall-positive-bias-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/58613-siemens-atellica-ch-toxicology-calibrator-recall-positive-bias-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1632-2023
Cite this page
“Siemens Atellica CH Toxicology Calibrator Recall: Positive Bias Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58613-siemens-atellica-ch-toxicology-calibrator-recall-positive-bias-risk. Based on FDA recall #Z-1632-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1632-2023%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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).
- Brand
Siemens Healthcare- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
US Nationwide and Worldwide Distribution Foreign: Argentina Australia Austria¿¿¿¿¿¿¿¿ Bahrain¿¿¿¿¿¿¿¿ Bangladesh Belgium¿¿¿¿¿¿¿¿ Bosnia¿Herzeg.¿ Brazil Canada Chile China Colombia Czech¿Republic¿ Egypt¿¿¿¿¿¿¿¿¿¿ Estonia¿¿¿¿¿¿¿¿ Finland¿¿¿¿¿¿¿¿ France¿¿¿¿¿¿¿¿¿ Georgia¿¿¿¿¿¿¿¿ Germany¿¿¿¿¿¿¿¿ Greece¿¿¿¿¿¿¿¿¿ Hong Kong Hungary¿¿¿¿¿¿¿¿ India Israel¿¿¿¿¿¿¿¿¿ Italy¿¿¿¿¿¿¿¿¿¿ Latvia¿¿¿¿¿¿¿¿¿ Malaysia Mexico Netherlands¿¿¿¿ Norway¿¿¿¿¿¿¿¿¿ Pakistan¿¿¿¿¿¿¿ Poland¿¿¿¿¿¿¿¿¿ Portugal¿¿¿¿¿¿¿ Republic of Korea Saudi¿Arabia¿¿¿ Serbia¿¿¿¿¿¿¿¿¿ Slovakia¿¿¿¿¿¿¿ South Africa Spain¿¿¿¿¿¿¿¿¿¿ Sweden¿¿¿¿¿¿¿¿¿ Taiwan Turkey¿¿¿¿¿¿¿¿¿ United¿Kingdom¿ Uruguay Vietnam
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1631-2023 | ADVIA Chemistry ToxAmmonia Calibrator- In vitro diagnostic use in the calibration of ethanol (ETOH_2), ammonia (AMM), acetaminophen (ACET), and salicylate (SAL) assays on the ADVIA¿ Chemistry systems Siemens Material Number (SMN): 10309217; UDI-DI: 00630414479286 Lot Numbers: 9520531 Exp.Date: 2023-05-31; 9520341 Exp. Date: 2024-03-31 | 447 unit US; 1537 units OUS |
| Z-1632-2023 | Atellica CH Toxicology Calibrator (TOX CAL)-The Atellica¿ CH Toxicology Calibrator (TOX CAL) is for in vitro diagnostic use in calibrating the Acet, ETOH and Sal assays using the Atellica¿ CH Analyzer Siemens Material Number (SMN): 11099440; UDi-DI: 00630414597614 Lot Numbers: 74285306 Exp. Date: 2023-05-31; 74536672 Exp Date: 2024-03-31; 74732386 Exp. Date: 2024-11-30 | 6546 units US; 3681 units OUS |
What to do — step by step
Contact Siemens
Reach out to Siemens Healthcare for specific instructions on how to handle affected units.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “US Nationwide and Worldwide Distribution Foreign: Argentina Australia Austria¿¿¿¿¿¿¿¿ Bahrain¿¿¿¿¿¿¿¿ Bangladesh Belgium¿¿¿¿¿¿¿¿ Bosnia¿Herzeg.¿ Brazil Canada Chile China Colombia Czech¿Republic¿ Egypt¿¿¿¿¿¿¿¿¿¿ Estonia¿¿¿¿¿¿¿¿…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 56 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-1632-2023 (April 5, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1632-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.