BEUDAMED
    FDA Enforcement Class III Terminated

    Optilite IgG4 Kit Product Code: LK009.OPT.A

    Recall: Z-1089-2017 · Reported February 1, 2017

    Enforcement

    Recall Number
    Z-1089-2017
    Event ID
    76131
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    The Binding Site Group, Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 1, 2017
    Initiation Date
    December 23, 2016
    Classification Date
    January 24, 2017
    Termination Date
    May 3, 2017
    Address
    8 Calthorpe Road, N/A, Birmingham, N/A, N/A, United Kingdom

    Description

    Optilite IgG4 Kit Product Code: LK009.OPT.A

    Reason

    A change to the lower end of the measuring range and product insert did not reflect the change.The measuring range provided in instrument parameters is correct but contradicts the information provided in the product insert

    Code Info

    Lot #401413

    Distribution

    U.S. distribution to the following; FL, TX, PA, CA, MA, WA, MI, CT. No foreign distribution.

    Quantity

    9 users