Device product
cobas¿ EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay
Z-1320-2015
Product summary
- Event
- Event 70355
- Status
- Terminated
- Classification
- Class III
- Quantity
- 190 kits
- Official record key
device-enforcement:Z-1320-2015
Official wording
Reason: False positive results for Exon 20 insertion mutations are being detected with the cobas¿ EGFR Mutation Test, kit batch T08661.
Code information: T08661
Distribution pattern: Foreign
Derived failure modes
-
Unknown
False positive results for Exon 20 insertion mutations are being detected with the cobas¿ EGFR Mutation Test, kit batch T08661.