BEUDAMED
    FDA Enforcement Class II Terminated

    Becton, Dickinson and Company, BBL Crystal Enteric/Nonfermenter ID Kit, Catalog # 24500, cartons of 20 kits, In-vitro diagnostic reagents for microbiological testing. The BBL Crystal Enteric/Nonfermentor (E/NF) identification (ID) System is for the identification of aerobic gram-negative bacteria that belong to the family Enterobacteriaceae as well as some of the more frequently isolated glucose fermenting and nonfermenting gram-negative bacilli.

    Recall: Z-0699-2013 · Reported January 30, 2013

    Enforcement

    Recall Number
    Z-0699-2013
    Event ID
    63958
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Co.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 30, 2013
    Initiation Date
    December 13, 2012
    Classification Date
    January 19, 2013
    Termination Date
    June 3, 2013
    Address
    BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD, 21152-0999, United States

    Description

    Becton, Dickinson and Company, BBL Crystal Enteric/Nonfermenter ID Kit, Catalog # 24500, cartons of 20 kits, In-vitro diagnostic reagents for microbiological testing. The BBL Crystal Enteric/Nonfermentor (E/NF) identification (ID) System is for the identification of aerobic gram-negative bacteria that belong to the family Enterobacteriaceae as well as some of the more frequently isolated glucose fermenting and nonfermenting gram-negative bacilli.

    Reason

    In-vitro diagnostic reagents for microbiological testing may be reversed in well positions in the test kit and when utilized may lead to bacteria misidentification.

    Code Info

    Lot Number/ Exp Date 2086315 February 20, 2013 2101435 February 20, 2013 2104316 February 27, 2013 2129460 February 27, 2013 2129487 March 13, 2013 2163211 February 27, 2013 2163213 March 20, 2013 2163215 March 27, 2013

    Distribution

    Worldwide Distribution-USA including the states of MA, TN, KY, IN, GA, NC, TX, NY, FL, AZ, WA, NJ, MI, and CA, and the countries of Uruguay, Taiwan, Singapore, Australia, South Korea, Mexico, Hong Kong, Guatemala, Colombia, Chile, Canada, India, Japan, Brazil, China and Belgium.

    Quantity

    67,820 units