cobas EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay
This recall has been terminated (originally issued March 25, 2015).
- Company
- Roche Molecular Systems, Inc.
- Recall Initiated
- January 13, 2015
- Posted
- March 25, 2015
- Terminated
- December 11, 2017
- Recall Number
- Z-1320-2015
- Quantity
- 190 kits
- Firm Location
- Branchburg, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
False positive results for Exon 20 insertion mutations are being detected with the cobas EGFR Mutation Test, kit batch T08661.
Distribution
Foreign
Lot / Code Info
T08661
Root Cause
Under Investigation by firm
Action Taken
RMS notified their customers on 1/13/2015.
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