Device recall
Z-0999-2015: cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test; CE-IVD 5852170190. Intended…
FDA device recall · Class III · Roche Molecular Systems, Inc.
Key facts
| Recall number (Z-number) | Z-0999-2015 |
|---|---|
| Recall event | 70058 |
| Product | cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test; CE-IVD 5852170190. Intended for the identification of mutations in codons 12,13 and 61 of the KRAS Gene in DNA derived from formalin-fixed paraffin-embedded human colorectal and non-small cell lung cancer tissues. |
| Product code | OWD |
| Recalling firm | Roche Molecular Systems, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Feb 8, 2017 |
| 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