BEUDAMED
    FDA Enforcement Class II Terminated

    Digital RID Plate Reader and Software Product Code: AD400

    Recall: Z-1055-2017 · Reported January 25, 2017

    Enforcement

    Recall Number
    Z-1055-2017
    Event ID
    76043
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    The Binding Site Group, Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 25, 2017
    Initiation Date
    October 9, 2012
    Classification Date
    January 19, 2017
    Termination Date
    April 4, 2017
    Address
    8 Calthorpe Road, Birmingham, N/A, United Kingdom

    Description

    Digital RID Plate Reader and Software Product Code: AD400

    Reason

    If a control ring is marked after reading, the software will not flag results that are out of the specified QC range.

    Code Info

    UDI 05051700000376

    Distribution

    U.S. distribution to the following; MA, GA, NY, IA, CA, IL, UT, NJ, NC, MD, MN. Foreign distribution to the following; UK, Germany, Spain, France.