BEUDAMED
    FDA Enforcement Class II Terminated

    VITROS¿ 3600 Immunodiagnostic System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum, plasma, urine and cerebrospinal fluid.

    Recall: Z-0652-2019 · Reported December 26, 2018

    Enforcement

    Recall Number
    Z-0652-2019
    Event ID
    81563
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ortho-Clinical Diagnostics
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 26, 2018
    Initiation Date
    October 19, 2018
    Classification Date
    December 20, 2018
    Termination Date
    January 24, 2022
    Address
    100 Indigo Creek Dr, Rochester, NY, 14626-5101, United States

    Description

    VITROS¿ 3600 Immunodiagnostic System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum, plasma, urine and cerebrospinal fluid.

    Reason

    Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.

    Code Info

    Product Code: 6802783 UDI 10758750002979 Product Code: 6802914 UDI 10758750007103 Serial Numbers: J36000109-J36001169

    Distribution

    US Nationwide Distribution

    Quantity

    682