BEUDAMED
    FDA Recall Open, Classified

    BD PCR Cartridges used with MAX System. Model Number: 437519

    Recall: Z-1004-2025 · Initiated December 19, 2024

    Recall

    Recall Number
    Z-1004-2025
    Event Number
    95963
    Firm
    Becton Dickinson & Co.
    FEI Number
    1119779
    Product Code
    NJR
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    December 19, 2024
    Posted
    January 21, 2025
    Address
    7 Loveton Cir, Sparks, MD, 21152-9212

    Description

    BD PCR Cartridges used with MAX System. Model Number: 437519

    Reason

    Potential for signal drift in specific lots of BD PCR Cartridges.

    Action

    BD notified consignees via email and mail on about 12/19/2024 with a letter titled, URGENT: Medical Device Product Correction. Consignees were informed regarding when they can and cannot use the affected BD PCR Cartridges. They were instructed to inspect inventory for affected cartridges, ensure the recall notification is read and understood by all affected personnel, to provide the notification to all affected personnel and customers if further distributed, to complete and return the Customer Response Form, and to report any adverse events associated with the affected units. Distributors were provided the same information and instructions, but were also instructed to provide a copy of the letter to their customers.

    Distribution

    Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Canada, South Korea, Taiwan, Australia, Singapore, Mexico, Hong Kong, India, Japan, Columbia, Brazil, Philippines, Argentina, New , Zealand, Uruguay, Chile, Trinidad and Tobago, Belgium, Vietnam, Macao.

    Quantity

    516,435 units