BEUDAMED
    FDA Enforcement Class III Terminated

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

    Recall: Z-1320-2015 · Reported April 1, 2015

    Enforcement

    Recall Number
    Z-1320-2015
    Event ID
    70355
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Roche Molecular Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 1, 2015
    Initiation Date
    January 13, 2015
    Classification Date
    March 25, 2015
    Termination Date
    December 11, 2017
    Address
    1080 Us Highway 202 S, Branchburg, NJ, 08876-3733, United States

    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.

    Code Info

    T08661

    Distribution

    Foreign

    Quantity

    190 kits