BEUDAMED
    FDA Recall Open, Classified

    BD COR System Software. Model Number: 444829.

    Recall: Z-2162-2025 · Initiated June 23, 2025

    Recall

    Recall Number
    Z-2162-2025
    Event Number
    97142
    Firm
    Becton Dickinson & Co.
    FEI Number
    1119779
    Product Code
    MAQ
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    June 23, 2025
    Posted
    July 23, 2025
    Address
    7 Loveton Cir, Sparks, MD, 21152-9212

    Description

    BD COR System Software. Model Number: 444829.

    Reason

    Potential for functionality issue that supports the Over labeling feature and could lead to possible false negative results.

    Action

    Becton, Dickinson and Company began notification of consignees on about 06/23/2025 via telephone call and followed by a letter. Consignees were instructed to note the outlined workflows when loading specimens with the Over labeling feature enabled and consider retesting affected specimens for HPV testing if affected. Consignees were also instructed to post the notification within their facility, notify customers if affected units were further distributed, and complete and return the provided Customer Response Form.

    Distribution

    Worldwide - US Nationwide distribution in the states of Florida, Texas and Michigan. The countries of Sweden and Belgium.

    Quantity

    7 systems