BEUDAMED
    FDA Enforcement Class II Ongoing

    CD11b APC: ASR, REF: 340936, and CE, REF: 333143

    Recall: Z-0641-2024 · Reported January 17, 2024

    Enforcement

    Recall Number
    Z-0641-2024
    Event ID
    93569
    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
    January 17, 2024
    Initiation Date
    October 25, 2023
    Classification Date
    January 5, 2024
    Address
    2350 Qume Dr, San Jose, CA, 95131-1812, United States

    Description

    CD11b APC: ASR, REF: 340936, and CE, REF: 333143

    Reason

    In vitro diagnostics product that impacts the quality of cell staining can cause low or dim fluorescence signal, which can lead to potential false negative results and misdiagnosis of hematological malignancy, delayed treatment, and the need for additional patient samples.

    Code Info

    REF/UDI-DI/Expiration: 340936/00382903409365/20250228; 333143/00382903331437/20250228

    Distribution

    Worldwide - US Nationwide distribution including in the states of IL, MN, FL, MI, MD, NC, NY, CA, GA, AR, KS, PA, NH, TX, OK, MA, MO, DC, AZ, IN, NJ, TN, WA, VA, CT and the countries of CA, BE, SG, HK, TW, BR, MY, IN, BO, PE, JP, MX, CL, KR, UY, AU.

    Quantity

    464 Vials