BEUDAMED
    FDA Enforcement Class II Terminated

    Analyte specific reagent. REF/UDI: 641408/641408-4012-1-1 (US); 641417/641417-1157-1-01 (OUS); 641399/641399-4012-1-01 (US Research Use Only) - Product Usage: CD45 is intended for in vitro diagnostic use in the identification of cells expressing the CD45 antigen, using a BD FAC brand flow cytometer. The flow cytometer must be equipped to detect light scatter and the appropriate fluorescence, and be equipped with appropriate software (such as BD CellQuest, BD CellQuest Pro, BD FACSDiva, or BD FACSCanto clinical software) for data acquisition and analysis.

    Recall: Z-1971-2020 · Reported May 20, 2020

    Enforcement

    Recall Number
    Z-1971-2020
    Event ID
    85461
    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
    May 20, 2020
    Initiation Date
    March 31, 2020
    Classification Date
    May 13, 2020
    Termination Date
    April 27, 2021
    Address
    2350 Qume Dr, N/A, San Jose, CA, 95131-1812, United States

    Description

    Analyte specific reagent. REF/UDI: 641408/641408-4012-1-1 (US); 641417/641417-1157-1-01 (OUS); 641399/641399-4012-1-01 (US Research Use Only) - Product Usage: CD45 is intended for in vitro diagnostic use in the identification of cells expressing the CD45 antigen, using a BD FAC brand flow cytometer. The flow cytometer must be equipped to detect light scatter and the appropriate fluorescence, and be equipped with appropriate software (such as BD CellQuest, BD CellQuest Pro, BD FACSDiva, or BD FACSCanto clinical software) for data acquisition and analysis.

    Reason

    False positive reaction on the reagent.

    Code Info

    Analyte specific reagent - BD CD45 APC-H7. REF/ Lot Number: 641408/9057729; 541417/9056804; 641399/9065949

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CT, FL, GA, IL, IN, LA, MA, MD, MI, MN, MO, NC, NH, NJ, NM, NV, NY, OH, OK, PA, TN, TX, VA, WA, WI and Puerto Rico. The countries of Argentina, Australia, Belgium, Brazil, Canada, China, Hong Kong, India, Japan, Korea, Malaysia, New Zealand, Singapore, Taiwan and Vietnam.

    Quantity

    1473 vials.