BEUDAMED
    FDA Recall Terminated

    Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and monitoring of Multiple Myeloma and related diseases.

    Recall: Z-1050-2017 · Initiated November 28, 2012

    Recall

    Recall Number
    Z-1050-2017
    Event Number
    76049
    Firm
    The Binding Site Group, Ltd.
    FEI Number
    3002808340
    Product Code
    DEH
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    November 28, 2012
    Posted
    January 19, 2017
    Terminated
    March 3, 2017
    Address
    8 Calthorpe Road, Birmingham United Kingdom

    Description

    Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and monitoring of Multiple Myeloma and related diseases.

    Reason

    Calibration curve activity has increased over time in the kit lots listed.

    Action

    Customer notification letters were sent 11/28/12. Customers were asked to discontinue using the listed kit lots. Discard any unused or partially-used kits of these lots. Let The Binding Site know how many replacement kits are required.

    Distribution

    U.S. distribution to the following; CA, TX, HI, GA, PA, UT, NY, OK, ID, MA, AZ. Foreign distribution to the following; Australia, Bulgaria, Denmark, Hong Kong, Ireland, Israel, Japan, New Zealand, Taiwan, Belgium, France, Italy, Spain.

    Quantity

    1,002