FDA Device recall Z-2476-2025
STA - Fibrinogen 5. Model/Catalog Number: 00674
- FDA Device
- Class II
- ongoing
- Published 2025-09-03
On 2025-09-03 the FDA classified a Class II recall of STA - Fibrinogen 5. Model/Catalog Number: 00674 by Diagnostica Stago, citing potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2476-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-07-21 |
| Published | 2025-09-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Diagnostica Stago |
| Distribution | US |
Product
STA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 kit is intended for use with the analyzers of the STA-R, STA Compact and STA Satellite families for the quantitative determination of fibrinogen levels in human citrated plasma by the clotting method of Clauss.
Reason
Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
Identifiers
| code_info | Model/Catalog Number: 00674. UDI-DI: 13607450006749 |
|---|
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-2476-2025%22
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