Device recall
Z-1320-2015: cobas EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay
FDA device recall · Class III · Roche Molecular Systems, Inc.
Key facts
| Recall number (Z-number) | Z-1320-2015 |
|---|---|
| Recall event | 70355 |
| Product | cobas EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay |
| Product code | OWD |
| Recalling firm | Roche Molecular Systems, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Dec 11, 2017 |
| PMA numbers | P120019 |
| FEI number | 2243471 |
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