Device recall
Z-2994-2018: Diagnostica Stago STA Noplastine CI, 10 ml vial. In-Vitro Diagnostic for…
FDA device recall · Class II · Diagnostica Stago, Inc.
Key facts
| Recall number (Z-number) | Z-2994-2018 |
|---|---|
| Recall event | 80826 |
| Product | Diagnostica Stago STA Noplastine CI, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. REF: 00666 The STA - Noplastine CI kits provide reagents for the determination of the prothrombin time (PT) in plasma with STA-R, STA Compact and STA Satellite. (In the USA… |
| Product code | GJS |
| Recalling firm | Diagnostica Stago, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 18, 2020 |
| 510(k) numbers | K922565 |
| FEI number | 2245451 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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