BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1320-2015 · Initiated January 13, 2015

    Recall

    Recall Number
    Z-1320-2015
    Event Number
    70355
    Firm
    Roche Molecular Systems, Inc.
    FEI Number
    2243471
    Product Code
    OWD
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    January 13, 2015
    Posted
    March 25, 2015
    Terminated
    December 11, 2017
    Address
    1080 Us Highway 202 S, Branchburg, NJ, 08876-3733

    Description

    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.

    Action

    RMS notified their customers on 1/13/2015.

    Distribution

    Foreign

    Quantity

    190 kits