BEUDAMED
    FDA Enforcement Class II 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 · Reported January 28, 2015

    Enforcement

    Recall Number
    Z-1000-2015
    Event ID
    70107
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    BD Biosciences, Systems & Reagents
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 28, 2015
    Initiation Date
    December 19, 2014
    Classification Date
    January 20, 2015
    Termination Date
    February 23, 2016
    Address
    2350 Qume Dr, N/A, San Jose, CA, 95131-1812, United States

    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.

    Code Info

    Lot number 4220622, Expiry 2016-04-30.

    Distribution

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

    Quantity

    165 units