Device recall
Z-0535-2020: FoundationOne CDx test report
FDA device recall · Class II · Foundation Medicine, Inc.
Key facts
| Recall number (Z-number) | Z-0535-2020 |
|---|---|
| Recall event | 83729 |
| Product | FoundationOne CDx test report |
| Product code | PQP |
| Recalling firm | Foundation Medicine, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 19, 2021 |
| PMA numbers | P170019 |
| FEI number | 3010679023 |
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