BEUDAMED
    FDA Recall Terminated

    BD MAX DNA MMK Lab Use, catalog no. 442828

    Recall: Z-1545-2018 · Initiated March 2, 2018

    Recall

    Recall Number
    Z-1545-2018
    Event Number
    79769
    Firm
    Becton Dickinson & Co. 7 Loveton Cir BD Diagnostic Systems
    FEI Number
    1119779
    Product Code
    PPM
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    March 2, 2018
    Terminated
    July 2, 2018
    Address
    Sparks, MD, 21152-9212

    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.

    Action

    On March 2, 2018, the firm sent Urgent Medical Device Product Advisory notices to customers via UPS. The notice identified the errors and the correct information, as well as potential health risks. Customers were asked to take the following actions: 1) Share the information with all users of the product within their facility to ensure awareness; 2) Complete the customer response form and return to the recalling firm; and 3) Report any associated adverse health consequences to the recalling firm. The recalling firm is not asking customer to send back product or discard. The recalling firm will provide users with an updated insert when available. BD Customer/Technical Support: 800-638-8663, Monday-Friday, 8:30AM-5PM (EST) for US customers.

    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.