Device recall
Z-0834-2013: VENTANA (a member of the Roche Group) DISCOVERY ULTRA; REF/MU 750-601; Research…
FDA device recall · Class II · Ventana Medical Systems Inc
Key facts
| Recall number (Z-number) | Z-0834-2013 |
|---|---|
| Recall event | 64244 |
| Product | VENTANA (a member of the Roche Group) DISCOVERY ULTRA; REF/MU 750-601; Research Use Only Product Usage: Research Use Only-The DISCOVERY ULTRA Advanced Staining System is intended to automatically stain histological or cytological specimens on microscope slides with specific inununohistochemistry or… |
| Product code | KPA |
| Recalling firm | Ventana Medical Systems Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 24, 2016 |
| FEI number | 1000125183 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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