BEUDAMED
    FDA Enforcement Class II Ongoing

    BD Trucount Tubes (Cat. No. 663028), used for determining absolute counts of leukocytes in blood. BD Trucount Tubes are designed for use with in vitro diagnostic products such as BD Tritest reagents, and a suitably equipped flow cytometer. BD Trucount Tubes can be used with the BD FACS Loader.

    Recall: Z-0172-2023 · Reported November 9, 2022

    Enforcement

    Recall Number
    Z-0172-2023
    Event ID
    90866
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Becton, Dickinson and Company, BD Biosciences
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 9, 2022
    Initiation Date
    October 3, 2022
    Classification Date
    November 3, 2022
    Address
    2350 Qume Dr, N/A, San Jose, CA, 95131-1812, United States

    Description

    BD Trucount Tubes (Cat. No. 663028), used for determining absolute counts of leukocytes in blood. BD Trucount Tubes are designed for use with in vitro diagnostic products such as BD Tritest reagents, and a suitably equipped flow cytometer. BD Trucount Tubes can be used with the BD FACS Loader.

    Reason

    Due to partial label detachment on tubes. This can cause tubes to become stuck together in the pouch or cause automation errors when used with the automated loader for the wash assistant. Firm root cause investigation confirmed that label detachment is due to an adhesive change by a tier 2 supplier.

    Code Info

    Corrected as of 11/04/2022: Catalog Number: 663028 UDI-DI Code: 00382906630285 Lot Numbers: 2031238 2063994 2095615 2145791 2221697 2237045

    Distribution

    U.S.: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, VT, WA, and WI O.U.S.: Argentina, Australia, Belgium, Bolivia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Hong Kong, India, Japan, Korea, Mexico, Malaysia, New Zealand, Panama, Peru, Philippines, Paraguay, Singapore, Thailand, Taiwan, and Uruguay

    Quantity

    11,709 tubes (corrected 11/04/2022)