BEUDAMED
    FDA Enforcement Class III Terminated

    BD MAX DNA MMK Lab Use, catalog no. 442828

    Recall: Z-1545-2018 · Reported May 9, 2018

    Enforcement

    Recall Number
    Z-1545-2018
    Event ID
    79769
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Co.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 9, 2018
    Initiation Date
    March 2, 2018
    Classification Date
    April 28, 2018
    Termination Date
    July 2, 2018
    Address
    7 Loveton Cir, BD Diagnostic Systems, Sparks, MD, 21152-9212, United States

    Description

    BD MAX DNA MMK Lab Use, catalog no. 442828

    Reason

    The package insert incorrectly lists the volume of the primer and probe diluent to use for the reconstitution of the master mix tube. Adding the incorrect amount of diluent could have an effect on the assay.

    Code Info

    All since 08/20/2014

    Distribution

    Distributed to accounts in 8 states: CA, FL, NJ, NY, OR, PA, VA, and WI. International distribution to Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Europe, Hong Kong, Japan, Singapore, Taiwan, and Thailand.

    Quantity

    N/A