BEUDAMED
    FDA Recall Terminated

    BBL[TM] Lysine Iron Agar, catalog #211363,500 g bottle 2014-03-31. Lysine Iron Agar was developed for use in the differentiation of enteric organisms based on their ability to decarboxylate or dominate lysine and to form hydrogen sulfide. Becton, Dickinson and Company, Sparks, MD 21152 USA 38800 Le Pont de Claix, France. Lysine Iron Agar was developed for the use for differentiation of enteric organisms, in particular Salmonella species due to its ability to decarboxylate or deaminate lysine and form hydrogen sulfide.

    Recall: Z-1109-2012 · Initiated January 11, 2012

    Recall

    Recall Number
    Z-1109-2012
    Event Number
    61006
    Firm
    Becton Dickinson & Co. BD Diagnostic Systems
    FEI Number
    1119779
    Product Code
    LKA
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    January 11, 2012
    Posted
    February 27, 2012
    Terminated
    March 30, 2012
    Address
    7 Loveton Circle, Sparks, MD, 21152-0999

    Description

    BBL[TM] Lysine Iron Agar, catalog #211363,500 g bottle 2014-03-31. Lysine Iron Agar was developed for use in the differentiation of enteric organisms based on their ability to decarboxylate or dominate lysine and to form hydrogen sulfide. Becton, Dickinson and Company, Sparks, MD 21152 USA 38800 Le Pont de Claix, France. Lysine Iron Agar was developed for the use for differentiation of enteric organisms, in particular Salmonella species due to its ability to decarboxylate or deaminate lysine and form hydrogen sulfide.

    Reason

    Lysine Iron Agar may not produce the correct biochemical reactions with Quality Control organisms over the shelf life of the product..

    Action

    BD Diagnostics Systems sent an "URGENT PRODUCT RECALL" letter dated January 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue use and discard any remaining packages. A form was attached for customers to complete and return via fax to: Attention: Regulatory Compliance at 410-316-4258. Contact the BD Technical Services Department at 1-800-638-8663 for questions regarding this recall.

    Distribution

    Worldwide Distribution-USA (nationwide) including the states of AL, AR, CA, CO, CT, DC, FL, GA, IL, IN, MI, MN, MO, NC, NE, NJ, NM, NY, OH, OR, PA, SD, TX, VA, and WI, and the countries of Belgium, Canada, Chile, China, Columbia, Costa Rica, Mexico, El Salvador, Ecuador, Japan, Manila, Singapore, Peru, Taiwan, and Venezuela.

    Quantity

    33 bottles