Device recall
Z-1503-2025: Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage…
FDA device recall · Class II · Fisher Diagnostics
Key facts
| Recall number (Z-number) | Z-1503-2025 |
|---|---|
| Recall event | 96488 |
| Product | Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor assays. |
| Product code | GJS |
| Recalling firm | Fisher Diagnostics |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K994100 |
| FEI number | 1181121 |
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