BEUDAMED
    FDA Enforcement Class III Terminated

    cobas¿ Liat Influenza A/B Quality Control Kit; For use with cobas¿ Liat Influenza A/B Assay.

    Recall: Z-2203-2016 · Reported July 20, 2016

    Enforcement

    Recall Number
    Z-2203-2016
    Event ID
    74154
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Roche Molecular Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 20, 2016
    Initiation Date
    May 17, 2016
    Classification Date
    July 13, 2016
    Termination Date
    February 1, 2017
    Address
    1080 US Highway 202 S, Branchburg, NJ, 08876-3733, United States

    Description

    cobas¿ Liat Influenza A/B Quality Control Kit; For use with cobas¿ Liat Influenza A/B Assay.

    Reason

    Kit labeled with the incorrect expiration date.

    Code Info

    Lot Numbers: 51222E, 60121H, 60201D, and 60229F

    Distribution

    Distributed in the states of: TX, NY, OR, HI, MD, PA, NC, MA, IA, WA, OR, AK, ME, MN, VA, MT, PA, and LA.

    Quantity

    194 distributed kits