BEUDAMED
    FDA Recall Terminated

    BD Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD); Catalog number 340383. Label states: Contains CD3 FITC/CD4 PE/CD45 per CP with Gelatin and 0.1% sodium azide. Hematology: BD Tritest CD3 fluorescein isothiocyanate (FITC)/CD4 phycoerythrin (PE)/CD45 peridinin chlorophyll protein (PerCP) is a three-color direct immunofluorescence reagent for use with a suitably equipped flow cytometer to identify and determine the percentages and absolute counts of mature human T lymphocytes (CD3+) and helper/inducer (CD3+CD4+) Tlymphocyte subsets in erythrocyte-lysed whole blood.

    Recall: Z-2378-2016 · Initiated July 18, 2016

    Recall

    Recall Number
    Z-2378-2016
    Event Number
    74788
    Firm
    Becton, Dickinson and Company, BD Biosciences
    FEI Number
    2916837
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    July 18, 2016
    Posted
    August 9, 2016
    Terminated
    March 1, 2017
    Address
    2350 Qume Dr, San Jose, CA, 95131-1812

    Description

    BD Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD); Catalog number 340383. Label states: Contains CD3 FITC/CD4 PE/CD45 per CP with Gelatin and 0.1% sodium azide. Hematology: BD Tritest CD3 fluorescein isothiocyanate (FITC)/CD4 phycoerythrin (PE)/CD45 peridinin chlorophyll protein (PerCP) is a three-color direct immunofluorescence reagent for use with a suitably equipped flow cytometer to identify and determine the percentages and absolute counts of mature human T lymphocytes (CD3+) and helper/inducer (CD3+CD4+) Tlymphocyte subsets in erythrocyte-lysed whole blood.

    Reason

    Internal review found that some vials of CD3/CD4/CD45 state that the product contains gelatin. The product does not contain gelatin and should state in buffer.

    Action

    BD Life Sciences sent an Urgent Product notification letter dated July 18, 2016 to all affected customers via UPS and/or e-mail. The letter informed the user of the issue and states that no action is required since product performance is not impacted. The response form is to be returned to BD as instructed. Customers requiring further assistance were instructed to contact BD Customer Support at 855-236-2772. For questions regarding this recall call 408-954-6080.

    Distribution

    Nationwide distribution to AR, CA, CO, IL, IN, LA, MA, MD, Ml, MN, NC, NJ, NM, NY, OR, PA, TN, TX, WA

    Quantity

    14,089