Device recall
Z-1764-2008: HerpeSelect 1 and 2 Immunoblot IgG Kit, IB0900G Intended for qualitatively…
FDA device recall · Class II · Focus Diagnostics Inc
Key facts
| Recall number (Z-number) | Z-1764-2008 |
|---|---|
| Recall event | 47459 |
| Product | HerpeSelect 1 and 2 Immunoblot IgG Kit, IB0900G Intended for qualitatively detecting the presence or absence of human IgG class antibodies to HSV-1 and HSV-2 in human sera. |
| Product code | LGC |
| Recalling firm | Focus Diagnostics Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 25, 2009 |
| 510(k) numbers | K000238 |
| FEI number | 2023365 |
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