Recall Z-1320-2015 ยท OWD Somatic Gene Mutation Detection System
Roche Molecular Systems, Inc.
cobas EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay
| Date | Mar 25, 2015 (initiated Jan 13, 2015) |
| Status | Terminated |
| Reason | False positive results for Exon 20 insertion mutations are being detected with the cobas EGFR Mutation Test, kit batch T08661. |
| Root cause | Under Investigation by firm |
| Action | RMS notified their customers on 1/13/2015. |
| Quantity | 190 kits |
| Distribution | Foreign |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.