BEUDAMED
    FDA Recall 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 · Initiated March 31, 2020

    Recall

    Recall Number
    Z-1971-2020
    Event Number
    85461
    Firm
    Becton, Dickinson and Company, BD Biosciences
    FEI Number
    2916837
    Product Code
    MVU
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 31, 2020
    Posted
    May 13, 2020
    Terminated
    April 27, 2021
    Address
    2350 Qume Dr, San Jose, CA, 95131-1812

    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.

    Action

    URGENT MEDICAL DEVICE RECALL letter was sent to the customers on 03/31/2020 via FedEx, emailed or faxed. The acknowledgement form included with the letter that is mailed, faxed, emailed, back to BD will be reconciled with the customer list.

    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.