Atellica CH Toxicology Calibrator — Class II medical device recall Z-1632-2023
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2023-05-31, distributed nationwide. Reassignment of the Atellica CH Toxicology Calibrators (TOX CAL) and ADVIA Chemistry ToxAmmonia Calibrators fo
| Recall number | Z-1632-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Tarrytown, NY, United States |
| Recall initiated | 2023-04-05 |
| Classified | 2023-05-25 |
| Reported by FDA | 2023-05-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BD, BE, BH, BR, CA, CL, CN, CO, CZ, DE, EE, EG, ES, FI, FR, GR, HK, HU, IL, IN, IT, KR, LV, MX, MY, NL, NO, PK, PL, PT, RS, SE, SK, TR, TW, UY, VN, ZA |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 00630414597614 |
| Lot numbers | 74285306, 74536672, 74732386 |
| Expiration dates | 2023-05-31, 2024-03-31, 2024-11-30 |
Product
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
Reason for 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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1632-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.