BEUDAMED
    FDA Recall Terminated

    BBL DrySlide Oxidase Kit, catalog number 231746 Product Usage: Presumptive diagnostic aid for gram-negative bacteria.

    Recall: Z-1423-2013 · Initiated April 12, 0013

    Recall

    Recall Number
    Z-1423-2013
    Event Number
    65089
    Firm
    Becton Dickinson & Co. BD Diagnostic Systems
    FEI Number
    1119779
    Product Code
    JTO
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    April 12, 0013
    Posted
    May 29, 2013
    Terminated
    September 28, 2013
    Address
    7 Loveton Circle, Sparks, MD, 21152-0999

    Description

    BBL DrySlide Oxidase Kit, catalog number 231746 Product Usage: Presumptive diagnostic aid for gram-negative bacteria.

    Reason

    In-vitro diagnostic agents were placed into incorrect packaging for distribution to microbiological laboratories.

    Action

    BD Diagnostic Systems sent an Urgent Product Recall" letter dated April 2013 to all affected consignees and end users. The letter identified the affected product, problem and actions to be taken. The notice instructed consignees and end users to discontinue use of the products, discard remaining products, and return a completed response form. Consignees were requested to provide contact information for end users who received recalled product in distribution, to allow for recall notice. The letter included instructions to report injuries and/or illnesses to Medwatch, and address recall inquiries to BD Technical Services at 1-800-638-8663.

    Distribution

    Worldwide Distribution - USA Nationwide and tthe countries of Australia, Canada, Europe, Hong Kong, Mexico, New Zealand, Singapore, and Taiwan.

    Quantity

    610 total test kits (PYR and Oxidase)