Device recall
Z-3010-2018: VENTANA anti-Helicobacter Pylori (SP48) PAB 250, Catalog Number 06425623001…
FDA device recall · Class I · Ventana Medical Systems Inc
Key facts
| Recall number (Z-number) | Z-3010-2018 |
|---|---|
| Recall event | 80807 |
| Product | VENTANA anti-Helicobacter Pylori (SP48) PAB 250, Catalog Number 06425623001, model 790-1015 Immunohistochemistry (IHC) for in vitro diagnostic use. |
| Product code | OWF |
| Recalling firm | Ventana Medical Systems Inc |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Nov 22, 2021 |
| 510(k) numbers | K101234 |
| FEI number | 1000125183 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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