BEUDAMED
    FDA Recall Terminated

    FMC7 FITC, Catalog No. 340918 Analyte Specific Reagent.

    Recall: Z-0628-2016 · Initiated December 14, 2015

    Recall

    Recall Number
    Z-0628-2016
    Event Number
    72885
    Firm
    Becton, Dickinson and Company, BD Biosciences
    FEI Number
    2916837
    Product Code
    MVU
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    December 14, 2015
    Posted
    January 11, 2016
    Terminated
    October 31, 2016
    Address
    2350 Qume Dr, San Jose, CA, 95131-1812

    Description

    FMC7 FITC, Catalog No. 340918 Analyte Specific Reagent.

    Reason

    Becton, Dickinson and Company (BD) has determined that the FMC7 FITC (ASR) is exhibiting functional degradation. The functional degradation has the effect of reducing the percent positive from 100% down to approximately 87%.

    Action

    BD Biosciences sent an Urgent Product Recall letter dated December 2015, to all affected customers to inform them that Becton, Dickinson and Company (BD) has determined that the FMC7 FITC (ASR) is exhibiting functional degradation. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to return the Tracking/Verification form to BD Biosciences. Customers are instructed to contact BD Customer Support at (877) 232-8995 (prompt 3, 3) in the US. Customers outside of the US are instructed to contact their local BD Biosciences or distributor.

    Distribution

    Nationwide Distribution

    Quantity

    1,388 units