BEUDAMED
    FDA Recall Terminated

    Fildes Enrichment, BBL brand, catalog #211866, in 5 ml tubes,10 tubes/package, manufactured by BD Diagnostic Systems, 250 Schilling Circle, Cockeysville, MD 21030. Fildes Enrichment may be used to enrich a variety of media for the cultivation of various microorganisms.

    Recall: Z-1282-2012 · Initiated February 20, 2012

    Recall

    Recall Number
    Z-1282-2012
    Event Number
    61305
    Firm
    Becton Dickinson & Co. BD Diagnostic Systems
    FEI Number
    1119779
    Product Code
    JSC
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 20, 2012
    Posted
    March 23, 2012
    Terminated
    June 18, 2012
    Address
    7 Loveton Circle, Sparks, MD, 21152-0999

    Description

    Fildes Enrichment, BBL brand, catalog #211866, in 5 ml tubes,10 tubes/package, manufactured by BD Diagnostic Systems, 250 Schilling Circle, Cockeysville, MD 21030. Fildes Enrichment may be used to enrich a variety of media for the cultivation of various microorganisms.

    Reason

    In vitro diagnostic reagent is defective and may fail to enhance the growth of microbiological cultures as intended.

    Action

    Becton Dickinson (BD) sent an "URGENT PRODUCT RECALL" letter dated February 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 affected product. BD will issue replacements for the discarded product. Additionally, an Acknowledgment Form was attached for customers to complete and return to the firm via fax to 410-316-4258. Contact BD Technical Services Department for questions regarding this notice.

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Japan, Mexico, and Taiwan.

    Quantity

    6930 tubes