Device recall
Z-2159-2012: Cobas KRAS Mutation Test for In Vitro Diagnostic Use Product Usage: Usage: The…
FDA device recall · Class III · Roche Molecular Systems, Inc.
Key facts
| Recall number (Z-number) | Z-2159-2012 |
|---|---|
| Recall event | 62500 |
| Product | Cobas KRAS Mutation Test for In Vitro Diagnostic Use Product Usage: Usage: The Cobas KRAS Mutation Test, for use with the Cobas 4800 System, is a real-time PCR test intended for the identification of mutations in codons 12, 13 and 61 of the KRAS gene in DNA derived from formalin-fixed… |
| Product code | OOI |
| Recalling firm | Roche Molecular Systems, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jul 16, 2013 |
| 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