Device recall
Z-2113-2014: InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro…
FDA device recall · Class II · Biogenex Laboratories, Inc.
Key facts
| Recall number (Z-number) | Z-2113-2014 |
|---|---|
| Recall event | 68709 |
| Product | InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use. |
| Product code | MVC |
| Recalling firm | Biogenex Laboratories, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 24, 2014 |
| FEI number | 2936532 |
At a glance
- None 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