FDA Device recall Z-3305-2024
Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)
- FDA Device
- Class II
- ongoing
- Published 2024-10-09
On 2024-10-09 the FDA classified a Class II recall of Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (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-3305-2024 |
| 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
Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (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 10995466 (100 Test) - 00630414597935; Material Number 10995467 (500 Test) - 00630414597942; Lot Number: 26098336 26099336 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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All Siemens Healthcare Diagnostics recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3305-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.