Device recall
Z-1699-2020: STA - Deficient VIII, Product Code: 00725. STA - Deficient VIII is an…
FDA device recall · Class II · Diagnostica Stago, Inc.
Key facts
| Recall number (Z-number) | Z-1699-2020 |
|---|---|
| Recall event | 85167 |
| Product | STA - Deficient VIII, Product Code: 00725. STA - Deficient VIII is an immuno-depleted human plasma intended for use in tests for the determination of factor VIII activity in plasma on STA-R and STA Compact analyzer platforms as follows: (A) STA-R Max, Product Codes: 58989, 58990 (B) STA-R Evolution… |
| Product code | GGP |
| Recalling firm | Diagnostica Stago, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 10, 2021 |
| 510(k) numbers | K892859 |
| 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