BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2203-2016 · Initiated May 17, 2016

    Recall

    Recall Number
    Z-2203-2016
    Event Number
    74154
    Firm
    Roche Molecular Systems, Inc.
    FEI Number
    2243471
    Product Code
    OCC
    Status
    Terminated
    Root Cause
    Incorrect or no expiration date
    Initiated
    May 17, 2016
    Posted
    July 13, 2016
    Terminated
    February 1, 2017
    Address
    1080 US Highway 202 S, Branchburg, NJ, 08876-3733

    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.

    Action

    An Urgent Medical Device Recall (UMDR) notice (Customer Letter) was sent to the 35 individual affected customer sites by UPS on May 17 2016. Customers were asked to take the following actions: " Discontinue use of cobas Liat Influenza A/B Quality Control kit lot numbers 51222E, 60121H, 60201D, and 60229F, and discard them per your local regulations. " Complete the enclosed UMDC faxback form (6941-00-0516) and fax it to 1-844-449-8506. " File this UMDC for future reference.

    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