BEUDAMED
    FDA Recall Terminated

    Gram Crystal Violet 250 mL, catalog #212525, in cartons of 4 bottles. Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.

    Recall: Z-2032-2012 · Initiated April 12, 2012

    Recall

    Recall Number
    Z-2032-2012
    Event Number
    61769
    Firm
    Becton Dickinson & Co. BD Diagnostic Systems
    FEI Number
    1119779
    Product Code
    JTS
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    April 12, 2012
    Posted
    July 18, 2012
    Terminated
    December 10, 2012
    Address
    7 Loveton Circle, Sparks, MD, 21152-0999

    Description

    Gram Crystal Violet 250 mL, catalog #212525, in cartons of 4 bottles. Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.

    Reason

    Potential for increase level of artifacts to appear as large, spherical and easy to distinguish or small & more difficult to distinguish from gram positive cocci.

    Action

    BD Diagnostic Systems sent an "URGENT PRODUCT RECALL" letter dated April 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 the affected product. An Acknowledgement Form was attached for customers to complete and return via fax to 410-316-4258. Contact the BD Customer Service Department for questions regarding this recall.

    Distribution

    Nationwide Distribution.

    Quantity

    878 cartons/ 3512 bottles