BEUDAMED
    FDA Enforcement Class II Ongoing

    BD Synapsys Informatics Solution, Catalog Number 444150

    Recall: Z-2099-2023 · Reported July 12, 2023

    Enforcement

    Recall Number
    Z-2099-2023
    Event ID
    92406
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Becton Dickinson & Co.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 12, 2023
    Initiation Date
    June 8, 2023
    Classification Date
    July 5, 2023
    Address
    7 Loveton Cir, N/A, Sparks, MD, 21152-9212, United States

    Description

    BD Synapsys Informatics Solution, Catalog Number 444150

    Reason

    There is a risk of mis-association of patient demographic data for users who choose to report results manually when their Service Control Unit (SCU) is operating near capacity and are using save actions (Skip, Final Discard, Mark as Read, Save) to process patient results rapidly.

    Code Info

    UDI-DI: 00382904441500;

    Distribution

    US States: CA, CO, IA, IL, MI, MN, MO, NY, OH, OK, SC, TN, TX, UT, WI. Australia, Austria, Belgium, Canada, Denmark, France, Germany, Italy, Japan, Luxembourg, Netherlands, New Zealand, Norway, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom

    Quantity

    102 systems