BEUDAMED
    FDA Recall Terminated

    BD Synapsys Laboratory Solutions Catalog Number:444150 Product Usage: BD Synapsys is a laboratory software solution providing data management and workflow management functionality across clinical diagnostic activities. The software integrates operational and clinical data points from laboratory hardware, with patient data received from external software systems allowing for the aggregation, evaluation, dissemination of knowledge using all data, anywhere, anytime. Currently Release 2 of BD Synapsys can connect to both Lab Automation (Kiestra) and BACTEC instruments.

    Recall: Z-1051-2019 · Initiated February 21, 2019

    Recall

    Recall Number
    Z-1051-2019
    Event Number
    82225
    Firm
    Becton Dickinson & Co.
    FEI Number
    1119779
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 21, 2019
    Terminated
    April 17, 2020
    Address
    7 Loveton Cir, Sparks, MD, 21152-9212

    Description

    BD Synapsys Laboratory Solutions Catalog Number:444150 Product Usage: BD Synapsys is a laboratory software solution providing data management and workflow management functionality across clinical diagnostic activities. The software integrates operational and clinical data points from laboratory hardware, with patient data received from external software systems allowing for the aggregation, evaluation, dissemination of knowledge using all data, anywhere, anytime. Currently Release 2 of BD Synapsys can connect to both Lab Automation (Kiestra) and BACTEC instruments.

    Reason

    BD Synapsys version 2.1 allowed the potential for a test order to be associated to an incorrect culture record.

    Action

    BD notified Synapsys Customer via letter UPS on 02/21/19 identified problem and action taken. Customer sites were updated remotely with a database update on January 10, 2019. Accounts asked to complete and return the CUSTOMER RESPONSE FORM BD Synapsys. The issue will be resolved by the software update syngo CT VB10A_SP1 (Service Pack 1) as soon as the update is available. For questions contact BD Customer/Technical Support at 8006388663. For customers outside the US, contact your local BD representative or distributor.

    Distribution

    Worldwide Distribution - US: Nationwide in the states of OH, IL, MO, TN and the countries of Netherlands

    Quantity

    5 sites