Device recall
Z-1971-2010: Sure-Vue HSV-2 Rapid Test, Catalogue No: 23-046395. 20 test Kit In Vitro…
FDA device recall · Class II · Biokit U.S.A. Inc.
Key facts
| Recall number (Z-number) | Z-1971-2010 |
|---|---|
| Recall event | 55316 |
| Product | Sure-Vue HSV-2 Rapid Test, Catalogue No: 23-046395. 20 test Kit In Vitro Diagnostic test for Herpes Simplex Virus 2 |
| Product code | LGC |
| Recalling firm | Biokit U.S.A. Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 26, 2012 |
| 510(k) numbers | K983886 |
| FEI number | 1000513333 |
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