Device recall
Z-2763-2017: Pacific Hemostasis FDP Latex Reagent, REF/Model Number 100651, UDI…
FDA device recall · Class II · Fisher Diagnostics
Key facts
| Recall number (Z-number) | Z-2763-2017 |
|---|---|
| Recall event | 77340 |
| Product | Pacific Hemostasis FDP Latex Reagent, REF/Model Number 100651, UDI 00845275000870, 1 x 5 mL, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company, LLC, a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA |
| Product code | KQJ |
| Recalling firm | Fisher Diagnostics |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 29, 2018 |
| 510(k) numbers | K800826 |
| FEI number | 1181121 |
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