ADVIA Centaur CA 19-9 — Class II medical device recall Z-3103-2024
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2024-09-18, distributed nationwide. Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous
| Recall number | Z-3103-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., East Walpole, MA, United States |
| Recall initiated | 2024-07-26 |
| Classified | 2024-09-11 |
| Reported by FDA | 2024-09-18 |
| Distributed | Nationwide (US) |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 00630414574257 |
| Lot numbers | 55970535, 55971535 |
Product
ADVIA Centaur CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN: 10491379 SMN: 11206239
Reason for recall
Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the Asia Pacific sample population. The observed bias is not proportional across the assay measuring interval and is less pronounced for sample results above a concentration of 110 U/mL.
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-3103-2024. 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.