BEUDAMED
    FDA Recall 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 · Initiated December 13, 2012

    Recall

    Recall Number
    Z-0699-2013
    Event Number
    63958
    Firm
    Becton Dickinson & Co. BD Diagnostic Systems
    FEI Number
    1119779
    Product Code
    JSS
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    December 13, 2012
    Posted
    January 20, 2013
    Terminated
    June 3, 2013
    Address
    7 Loveton Circle, Sparks, MD, 21152-0999

    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.

    Action

    Becton Dickinson initiated the recall by letter to direct accounts on 12/13/2012. Ex-US BD sites were notified via email, distributors were notified by fax and customer letters were delivered by UPS ground. The notification advised that the recalled kit contained citrate (CIT} and malonic acid (MLO} reagents in the reversed prong/well positions. Customers were advised to discontinue use of identified lot numbers and discard any remaining packages for replacements, and also to return the enclosed reply form. The recalling firm requested distributors to submit their customer list for direct BD notification to all end users. Contact the BD Customer Service Department at 1-800-638-8663 if further assistance is required.

    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