Device recall
Z-0571-2008: Ventana Image Analysis System (VIAS) - PATHWAY anti-HER-2/neu (4B5) primary…
FDA device recall · Class II · Ventana Medical Systems Inc
Key facts
| Recall number (Z-number) | Z-0571-2008 |
|---|---|
| Recall event | 45798 |
| Product | Ventana Image Analysis System (VIAS) - PATHWAY anti-HER-2/neu (4B5) primary antibody with software version 2.3.0.2, Model Number: VIAS-799-10000-00, Pathology Image Analysis System, Ventana Medical Systems, Inc., Tucson, AZ 85755 |
| Product code | NQN |
| Recalling firm | Ventana Medical Systems Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 26, 2012 |
| 510(k) numbers | K061613 |
| FEI number | 1000125183 |
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