BEUDAMED
    FDA Recall Terminated

    Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems

    Recall: Z-1578-2016 · Initiated March 3, 2016

    Recall

    Recall Number
    Z-1578-2016
    Event Number
    73680
    Firm
    Roche Molecular Systems, Inc.
    FEI Number
    2243471
    Product Code
    JJH
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    March 3, 2016
    Posted
    April 27, 2016
    Terminated
    May 25, 2017
    Address
    1080 US Highway 202 S, Branchburg, NJ, 08876-3733

    Description

    Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems

    Reason

    The hand-held barcode scanner model IT3800 used with the COBAS AmpliPrep instrument mis-identified a sample barcode ID.

    Action

    Roche Molecular Systems sent an "Urgent Medical Device Correction (UMDC) notification letter dated March 3, 2016, to their affected customers. Customers were instructed to provide the UMDC to other affected parties who may need to be aware of this issue. Customers were asked to complete the attached fax form and fax it to 1-866-737-5396. Customers with questions should contact Roche Support Network Customer Support Center at 1-800-526-1247. For questions regarding this recall call 908-253-7200.

    Distribution

    Nationwide Distribution

    Quantity

    6,939 pieces