FDA Device recall Z-3304-2024
ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test)
- FDA Device
- Class II
- ongoing
- Published 2024-10-09
On 2024-10-09 the FDA classified a Class II recall of ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test) by Siemens Healthcare Diagnostics, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3304-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-08-21 |
| Published | 2024-10-09 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test)
Reason
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.
Identifiers
| code_info | UDI-DI: Material Number 10630886 (100 Test) - 00630414587837; Material Number 10630887 (500 Test) - 00630414587844; L…UDI-DI: Material Number 10630886 (100 Test) - 00630414587837; Material Number 10630887 (500 Test) - 00630414587844; Lot Number: 26053337 26054337 26051337 26052337 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3304-2024%22
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