Class II — Siemens Healthcare Diagnostics, Inc.
| Recalling firm | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
|---|---|
| Registered facility | View this company's 12 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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 |
| Product | 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 |
| Quantity | 447 unit US; 1537 units OUS |
| Distribution | US Nationwide and Worldwide Distribution Foreign: Argentina Australia Austria® Bahrain® Bangladesh Belgium® BosniaHerzeg. Brazil Canada Chile China Colombia CzechRepublic® Egypt® Estonia® Finland® France® Georgia® Germany® Greece® Hong Kong Hungary® India Israel® Italy® Latvia® Malaysia Mex… |
| Initiated | 2023-04-05 |
| Classified | 2023-05-25 |
| Recall number | Z-1631-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Siemens Healthcare Diagnostics, Inc. (Z-1631-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/92179/
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