cobas EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay
FDA device recall Z-1320-2015 · posted 2015-03-25 · Terminated
Recall details
- Recalling firm
- Roche Molecular Systems, Inc.
- Reason for recall
- False positive results for Exon 20 insertion mutations are being detected with the cobas EGFR Mutation Test, kit batch T08661.
- Action taken
- RMS notified their customers on 1/13/2015.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- OWD
- Quantity affected
- 190 kits
- Distribution
- Foreign
- Date initiated
- 2015-01-13
- Date posted
- 2015-03-25
- Date terminated
- 2017-12-11
- Location
- S Branchburg, NJ
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