BEUDAMED
    FDA Enforcement Class III Terminated

    cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test; CE-IVD 5852170190. Intended for the identification of mutations in codons 12,13 and 61 of the KRAS Gene in DNA derived from formalin-fixed paraffin-embedded human colorectal and non-small cell lung cancer tissues.

    Recall: Z-0999-2015 · Reported January 28, 2015

    Enforcement

    Recall Number
    Z-0999-2015
    Event ID
    70058
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Roche Molecular Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 28, 2015
    Initiation Date
    December 18, 2014
    Classification Date
    January 20, 2015
    Termination Date
    February 8, 2017
    Address
    1080 Us Highway 202 S, N/A, Branchburg, NJ, 08876-3733, United States

    Description

    cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test; CE-IVD 5852170190. Intended for the identification of mutations in codons 12,13 and 61 of the KRAS Gene in DNA derived from formalin-fixed paraffin-embedded human colorectal and non-small cell lung cancer tissues.

    Reason

    cobas KRAS Mutation Kit T10786 is generating invalid results for the Mutant Control and/or KRAS Calibrator.

    Code Info

    Lots T10786 T13091, T15435, T15475, T14777, and W00389

    Distribution

    Foreign Distributed.

    Quantity

    660 pieces