Device recall
Z-2425-2018: PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to determine PD-L1 levels…
FDA device recall · Class II · Dako North America Inc.
Key facts
| Recall number (Z-number) | Z-2425-2018 |
|---|---|
| Recall event | 79602 |
| Product | PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to determine PD-L1 levels for determination of patient treatment options. |
| Product code | PLS |
| Recalling firm | Dako North America Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 10, 2020 |
| PMA numbers | P150013, P150013S006 |
| FEI number | 2022180 |
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