BEUDAMED
    FDA Enforcement Class II 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 · Reported July 25, 2012

    Enforcement

    Recall Number
    Z-2032-2012
    Event ID
    61769
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Co.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 25, 2012
    Initiation Date
    April 12, 2012
    Classification Date
    July 18, 2012
    Termination Date
    December 10, 2012
    Address
    BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD, 21152-0999, United States

    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.

    Code Info

    Lots 1325324 Exp May 31,2013 and 2011746, Exp July 31,2013

    Distribution

    Nationwide Distribution.

    Quantity

    878 cartons/ 3512 bottles