BEUDAMED
    FDA Enforcement Class III Terminated

    FMC7 FITC, Catalog No. 340918 Analyte Specific Reagent.

    Recall: Z-0628-2016 · Reported January 20, 2016

    Enforcement

    Recall Number
    Z-0628-2016
    Event ID
    72885
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton, Dickinson and Company, BD Biosciences
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 20, 2016
    Initiation Date
    December 14, 2015
    Classification Date
    January 11, 2016
    Termination Date
    October 31, 2016
    Address
    2350 Qume Dr, N/A, San Jose, CA, 95131-1812, United States

    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%.

    Code Info

    Lot No. 4162520, 4206855, 4267919, 4276818, 4309977, 5009530, 5036624, 5085573, 5182818

    Distribution

    Nationwide Distribution

    Quantity

    1,388 units