BEUDAMED
    FDA Recall Terminated

    CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. Hematology: Single color direct immunofluorescence reagent for enumerating percentages of mature human suppressor/cytotoxic (CD8+) lymphocytes in erythrocyte-lysed whole blood or peripheral blood mononuclear cell suspensions.

    Recall: Z-1000-2015 · Initiated December 19, 2014

    Recall

    Recall Number
    Z-1000-2015
    Event Number
    70107
    Firm
    BD Biosciences, Systems & Reagents
    FEI Number
    2916837
    Product Code
    GKL
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 19, 2014
    Posted
    January 20, 2015
    Terminated
    February 23, 2016
    Address
    2350 Qume Dr, San Jose, CA, 95131-1812

    Description

    CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. Hematology: Single color direct immunofluorescence reagent for enumerating percentages of mature human suppressor/cytotoxic (CD8+) lymphocytes in erythrocyte-lysed whole blood or peripheral blood mononuclear cell suspensions.

    Reason

    One lot of CD8 PE is contaminated with CD4 FITC and may cause an unexpected staining pattern and incorrect patient data.

    Action

    Recall notification letters were sent to all consignees on December 19, 2014 by certified mail.

    Distribution

    Worldwide distribution. US Nationwide including Puerto Rico, China, Brazil, Japan, Guatemala, India, New Zealand, Australia, Canada, Thailand, Chile and Malaysia.

    Quantity

    165 units