BEUDAMED
    FDA Recall Terminated

    Optilite IgG4 Kit Product Code: LK009.OPT.A

    Recall: Z-1089-2017 · Initiated December 23, 2016

    Recall

    Recall Number
    Z-1089-2017
    Event Number
    76131
    Firm
    The Binding Site Group, Ltd.
    FEI Number
    3002808340
    Product Code
    CFN
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    December 23, 2016
    Terminated
    May 3, 2017
    Address
    8 Calthorpe Road, Birmingham 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

    Action

    Customer notification letters were sent on 12/23/16. The Binding Site recommends to continue testing on the kit as normal and refer to the measuring ranges and limit of quantification stated in the notice and as indicated in the amended insert (INS009.OPT.A, Version: 21st December 2016) provided with this notification. The notice needs to be passed on to all those who need to be aware within the organization or to any Organization where the potentially affected devices have been transferred. Return the completed E-Back Form to your local Binding Site Representative for records and note that The Binding Site intends to report this correction to the FDA recall coordinator. If you have any questions contact Technical Services.

    Distribution

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

    Quantity

    9 users