Device recall
Z-2717-2011: iView DAB Detection Kit, Part number: 760-091 (05266157001) This detection kit…
FDA device recall · Class II · Ventana Medical Systems Inc
Key facts
| Recall number (Z-number) | Z-2717-2011 |
|---|---|
| Recall event | 58855 |
| Product | iView DAB Detection Kit, Part number: 760-091 (05266157001) This detection kit is intended for in vitro diagnostic use. Ventana Medical Systems' (Ventana) iVIEW DAB Detection Kit is an indirect biotin streptavidin system for detecting mouse IgG, mouse IgM and rabbit primary antibodies. The kit is… |
| Product code | MYA |
| Recalling firm | Ventana Medical Systems Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 10, 2012 |
| 510(k) numbers | K984567, K990618 |
| 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