Recall Z-0999-2015 ยท OWD Somatic Gene Mutation Detection System
Roche Molecular Systems, Inc.
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.
| Date | Jun 26, 2015 (initiated Dec 18, 2014) |
| Status | Terminated |
| Reason | cobas KRAS Mutation Kit T10786 is generating invalid results for the Mutant Control and/or KRAS Calibrator. |
| Root cause | Device Design |
| Action | RMS issued an Urgent Field Safety Notice on 12/18/2014. A Quality Notification was provided to all users of the of cobas KRAS Mutation Kit CE-IVD, lots T13091, T15435, T15475, T14777, and W00389, informing them of the issue and instructing them to discontinue use and discard any remaining inventory immediately. |
| Quantity | 660 pieces |
| Distribution | Foreign Distributed. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.