Device recall
Z-1146-2010: VENTANA PATHWAY anti-HER-2/neu (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY (PATHWAY…
FDA device recall · Class II · Ventana Medical Systems Inc
Key facts
| Recall number (Z-number) | Z-1146-2010 |
|---|---|
| Recall event | 53597 |
| Product | VENTANA PATHWAY anti-HER-2/neu (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY (PATHWAY HER2 (4B5)); Model Number: 790-2991, Lot number: 680957, in vitro diagnostic. |
| Product code | MVC |
| Recalling firm | Ventana Medical Systems Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 22, 2010 |
| PMA numbers | P990081 |
| FEI number | 1000125183 |
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