Device recall
Z-0188-2013: cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche Molecular…
FDA device recall · Class III · Roche Molecular Systems, Inc.
Key facts
| Recall number (Z-number) | Z-0188-2013 |
|---|---|
| Recall event | 63310 |
| Product | cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche Molecular Systems, Inc., Product Usage: The primary use of the cobas 4800 BRAF V600 Mutation Test is the detection of the BRAF V600 mutations in DNA extracted from formalin-fixed, paraffin-embedded human melanoma tissue. It is… |
| Product code | OWD |
| Recalling firm | Roche Molecular Systems, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Sep 11, 2013 |
| PMA numbers | P110020 |
| 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