Device recall
Z-2476-2025: STA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 kit is…
FDA device recall · Class II · Diagnostica Stago, Inc.
Key facts
| Recall number (Z-number) | Z-2476-2025 |
|---|---|
| Recall event | 97287 |
| 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. |
| Product code | KQJ |
| Recalling firm | Diagnostica Stago, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K840211 |
| FEI number | 2245451 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database