BEUDAMED
    FDA Enforcement Class II Terminated

    enGen Track System with TCAutomation Software Version 4.2

    Recall: Z-0254-2018 · Reported December 20, 2017

    Enforcement

    Recall Number
    Z-0254-2018
    Event ID
    77172
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ortho-Clinical Diagnostics
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 20, 2017
    Initiation Date
    April 26, 2017
    Classification Date
    December 14, 2017
    Termination Date
    August 23, 2021
    Address
    100 Indigo Creek Dr, N/A, Rochester, NY, 14626-5101, United States

    Description

    enGen Track System with TCAutomation Software Version 4.2

    Reason

    A software anomaly with TCA Software V4.2 may potentially cause a delay in reporting of results due to patient samples being routed to an unintended location when samples are reintroduced back onto the enGEN track

    Code Info

    Serial numbers: 5GV6W2J, 3RHC23J, 7KSC15J, 953252, CXL941J & JG7BFB5J Product Code 952019-EG, 952020-EG, 952055

    Distribution

    Domestically - GA, IL, MO, NC & NY; Internationally - Canada, England, France, Italy & Spain

    Quantity

    16