Device recall
Z-0907-2023: VENTANA PD-L1 (SP142) VENTANA PD-L1 (SP142) Assay (Class III, US IVD)…
FDA device recall · Class II · Ventana Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-0907-2023 |
|---|---|
| Recall event | 91199 |
| Product | VENTANA PD-L1 (SP142) VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 07709374001 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 08008540001 VENTANA PD-L1 (SP142) IHC Assay (CE IVD Analytical) 07011571001 |
| Product code | PLS |
| Recalling firm | Ventana Medical Systems, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P160002, P160002S017 |
| 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