BEUDAMED
    FDA Enforcement Class II Terminated

    BD CD64 APC-R700; Analyte Specific Reagent; Model 657701; Lot No. 4344945, 5037611 and 5063945. Hematology - used as analyte specific reagent - contamination leads to possibility of unexpected staining pattern.

    Recall: Z-0334-2016 · Reported December 2, 2015

    Enforcement

    Recall Number
    Z-0334-2016
    Event ID
    72548
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton, Dickinson and Company, BD Biosciences
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 2, 2015
    Initiation Date
    October 30, 2015
    Classification Date
    November 24, 2015
    Termination Date
    May 27, 2016
    Address
    2350 Qume Dr, N/A, San Jose, CA, 95131-1812, United States

    Description

    BD CD64 APC-R700; Analyte Specific Reagent; Model 657701; Lot No. 4344945, 5037611 and 5063945. Hematology - used as analyte specific reagent - contamination leads to possibility of unexpected staining pattern.

    Reason

    Three lots of CD64 (MD22) are contaminated with CD4 antibody.

    Code Info

    Model 657701; Lot No. 4344945, 5037611, both with expiry date of 31 DEC 2015; and 5063945 with expiry dte of 29 FEB 2016.

    Distribution

    Distributed in the states of FL, WA, PA, IL, GA, RI, TX, ND, and IA.

    Quantity

    23 vials