Device recall
Z-0629-03: Simplasitin Excel, 10 x 6ml, 25200, For Prothrombin Time determinations…
FDA device recall · Class II · Biomerieux, Inc.
Key facts
| Recall number (Z-number) | Z-0629-03 |
|---|---|
| Recall event | 25587 |
| Product | Simplasitin Excel, 10 x 6ml, 25200, For Prothrombin Time determinations, bioMerieux, Inc. Durham, NC 27704. The product consists of two vials, a thromboplastin reagent and a diluent ( the vials are mixed together before use). |
| Product code | GJS |
| Recalling firm | Biomerieux, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 21, 2004 |
| 510(k) numbers | K864283 |
| FEI number | 1039284 |
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