BEUDAMED
    FDA Enforcement Class II Terminated

    VITROS 3600 Immunodiagnostic System, Catalog Number 6802783, IVD --- Ortho Clinical Diagnostics. For use in the in vitro quantitative, semi-quantitative and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents.

    Recall: Z-0967-2015 · Reported January 21, 2015

    Enforcement

    Recall Number
    Z-0967-2015
    Event ID
    69830
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ortho-Clinical Diagnostics
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    January 21, 2015
    Initiation Date
    November 19, 2014
    Classification Date
    January 14, 2015
    Termination Date
    May 21, 2018
    Address
    100 Indigo Creek Dr, Rochester, NY, 14626-5101, United States

    Description

    VITROS 3600 Immunodiagnostic System, Catalog Number 6802783, IVD --- Ortho Clinical Diagnostics. For use in the in vitro quantitative, semi-quantitative and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents.

    Reason

    Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and below, and determined that the software may not properly identify an expired calibration.

    Code Info

    Software Version 3.1 & Below; Serial Numbers J36000101 - J36000834 (the serial numbers are sequential; J Numbers are analogous to serial numbers)

    Distribution

    Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela.

    Quantity

    658 total: USA - 144, Foreign - 514