BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1423-2013 · Reported June 5, 2013

    Enforcement

    Recall Number
    Z-1423-2013
    Event ID
    65089
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Co.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    June 5, 2013
    Initiation Date
    April 12, 2013
    Classification Date
    May 28, 2013
    Termination Date
    September 28, 2013
    Address
    BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD, 21152-0999, United States

    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.

    Code Info

    Oxidase kit - lot 2222008 with expiration date 08/31/13

    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)