Device recall
Z-1227-2023: BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein C…
FDA device recall · Class II · Aniara Diagnostica LLC
Key facts
| Recall number (Z-number) | Z-1227-2023 |
|---|---|
| Recall event | 91618 |
| Product | BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein C activity on human citrated plasma. Protein C is a glycoprotein, vitamin K dependent, which inhibits coagulation. Protein C in plasma is measured following a specific activation with Protac (Agkistrodom Contortrix), an… |
| Product code | GGP |
| Recalling firm | Aniara Diagnostica LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K050365 |
| FEI number | 3005017664 |
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