BEUDAMED
    FDA Enforcement Class II Terminated

    BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10

    Recall: Z-1018-2022 · Reported May 11, 2022

    Enforcement

    Recall Number
    Z-1018-2022
    Event ID
    89896
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Co.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 11, 2022
    Initiation Date
    March 9, 2022
    Classification Date
    April 29, 2022
    Termination Date
    January 19, 2024
    Address
    7 Loveton Cir, N/A, Sparks, MD, 21152-9212, United States

    Description

    BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10

    Reason

    When updating BD Kiestra customers to BD Synapsys version 4.10, the custom antibiotic codes set by the customer are overwritten with the BD default antibiotic codes.

    Code Info

    All systems running BD Synapsys version 4.10; UDI: 00382904441500; Serial Numbers: SL00530 SL00515 SL00527 SL00502 SL00540 SL00564 SL00549 SL00509 SL00003 SL00004 SL00010 SL00001 SL00005 SL00002 SL000015 SL01010 SL01022

    Distribution

    Worldwide distribution US Nationwide distribution in the states of CA, IL, MI, NY, OH, SC, and TN. The countries of Austria, France, Germany, Netherlands, Sweden.

    Quantity

    15 systems