BEUDAMED
    FDA Enforcement Class II Ongoing

    BD BBL TB Stain Kit K, Catalog (REF): 212522

    Recall: Z-1296-2025 · Reported March 12, 2025

    Enforcement

    Recall Number
    Z-1296-2025
    Event ID
    96244
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Becton Dickinson & Co.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 12, 2025
    Initiation Date
    February 12, 2025
    Classification Date
    March 6, 2025
    Address
    7 Loveton Cir, Sparks, MD, 21152-9212, United States

    Description

    BD BBL TB Stain Kit K, Catalog (REF): 212522

    Reason

    One component of the kit was shipped with an expiration date of 30Sep2024 while the Certificate of Analysis (COA) indicated an expiration date of 30Apr2025.

    Code Info

    Catalog (REF): 212522; UDI-DI: 00382902125228; Expiration Date: 2025/04/30; Date of Manufacture: 07/10/2024; Lot Number: 4191205;

    Distribution

    Domestic: AZ, CA, CO, GA, KY, IL, IN, NC, NJ, NY, MA, MD, TX, WA. International: Singapore, New Zealand, Chile, Australia, Taiwan, Malaysia.

    Quantity

    247 units