Recall Z-1320-2015— Roche Molecular Systems, Inc.
Class III · Terminated
Class III FDA medical device recall by Roche Molecular Systems, Inc., initiated 2015-01-13, terminated 2017-12-11. FDA's recall record names no specific 510(k) clearance for this event. Product: cobas¿ EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay. Reason: False positive results for Exon 20 insertion mutations are being detected with the cobas¿ EGFR Mutation Test, kit batch T08661..
- Recalling firm
- Roche Molecular Systems, Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2015-01-13
- Terminated
- 2017-12-11
- Firm location
- Branchburg, NJ, United States
Product description
cobas¿ EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay
Reason for recall
False positive results for Exon 20 insertion mutations are being detected with the cobas¿ EGFR Mutation Test, kit batch T08661.
Data sourced from openFDA. This site is unofficial and independent of the FDA.