ADVIA Centaur aTPO Assay — Class II medical device recall Z-3304-2024
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2024-10-09, distributed nationwide. Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the table below w
| Recall number | Z-3304-2024 |
|---|---|
| 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 | 2024-08-21 |
| Classified | 2024-09-27 |
| Reported by FDA | 2024-10-09 |
| Distributed | Nationwide (US) |
| Quantity | 5,622 kits |
| UPC / GTIN / UDI-DI | 00630414587837, 00630414587844 |
| Lot numbers | 26051337, 26052337, 26053337, 26054337 |
Product
ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test)
Reason for recall
Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the table below when compared to alternate lots on the Atellica IM analyzer.
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-3304-2024. 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.