BEUDAMED
    FDA Recall 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 · Initiated December 18, 2014

    Recall

    Recall Number
    Z-0999-2015
    Event Number
    70058
    Firm
    Roche Molecular Systems, Inc.
    FEI Number
    2243471
    Product Code
    OWD
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 18, 2014
    Posted
    June 26, 2015
    Terminated
    February 8, 2017
    Address
    1080 Us Highway 202 S, Branchburg, NJ, 08876-3733

    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.

    Action

    RMS issued an Urgent Field Safety Notice on 12/18/2014. A Quality Notification was provided to all users of the of cobas KRAS Mutation Kit CE-IVD, lots T13091, T15435, T15475, T14777, and W00389, informing them of the issue and instructing them to discontinue use and discard any remaining inventory immediately.

    Distribution

    Foreign Distributed.

    Quantity

    660 pieces