BEUDAMED
    FDA Enforcement Class II Terminated

    VITROS 350 Chemistry System, clinical chemistry analyzer

    Recall: Z-2177-2019 · Reported August 14, 2019

    Enforcement

    Recall Number
    Z-2177-2019
    Event ID
    83322
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ortho Clinical Diagnostics
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 14, 2019
    Initiation Date
    July 8, 2019
    Classification Date
    August 6, 2019
    Termination Date
    October 19, 2023
    Address
    100 Indigo Creek Dr, N/A, Rochester, NY, 14626-5101, United States

    Description

    VITROS 350 Chemistry System, clinical chemistry analyzer

    Reason

    Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System

    Code Info

    product code: 6802153 UDI: 10758750002054 Affected software : Version 9.7

    Distribution

    Worldwide distribution. US nationwide including Puerto Rico, Brazil, Canada, Chile, France, India, and Philippines.

    Quantity

    30