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Terminated

cobas EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay

FDA Recall Z-1320-2015 · Posted 2015-03-25

Recalling FirmRoche Molecular Systems, Inc.
Recall StatusTerminated
Product CodeOWD
Date Initiated2015-01-13
Date Terminated2017-12-11
Product Quantity190 kits

Reason for Recall

False positive results for Exon 20 insertion mutations are being detected with the cobas EGFR Mutation Test, kit batch T08661.

Firm Action

RMS notified their customers on 1/13/2015.

Root Cause

Under Investigation by firm

Distribution Pattern

Foreign

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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