BEUDAMED
    FDA Recall Terminated

    CD4 (SK3), FITC; Contains CD4 FITC with gelatin and 0.1% sodium Azide. Catalog number 340133 in vitro diagnostic used in Hematology: The SK3 monoclonal antibody reacts with human CD4, a 59-kDa cell surface receptor expressed by a majority of thymocytes, a subpopulation of mature T helper cells, and at low levels on monocytes. CD4 is a receptor for the human immunodeficiency virus (HIV).

    Recall: Z-2817-2015 · Initiated August 27, 2015

    Recall

    Recall Number
    Z-2817-2015
    Event Number
    72071
    Firm
    Becton, Dickinson and Company, BD Biosciences
    FEI Number
    2916837
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    August 27, 2015
    Posted
    September 24, 2015
    Terminated
    August 9, 2016
    Address
    2350 Qume Dr, San Jose, CA, 95131-1812

    Description

    CD4 (SK3), FITC; Contains CD4 FITC with gelatin and 0.1% sodium Azide. Catalog number 340133 in vitro diagnostic used in Hematology: The SK3 monoclonal antibody reacts with human CD4, a 59-kDa cell surface receptor expressed by a majority of thymocytes, a subpopulation of mature T helper cells, and at low levels on monocytes. CD4 is a receptor for the human immunodeficiency virus (HIV).

    Reason

    CD4 FITC label contains an error in the Spanish small text - it states CD8 FITC.

    Action

    Urgent Product Recall notification letters were sent to each customer on August 27, 2015 by certified mail.

    Distribution

    Worldwide Distribution. US nationwide (TX, CA, NC, OH, SD, PA, CT, UT, MD, TX, GA), Argentina, Taiwan, Australia, Japan, China, New Zealand, Chile and Colombia.

    Quantity

    128 units