BEUDAMED
    FDA Enforcement Class II Terminated

    VITROS ECi Immunodiagnostic System Refurbished Product Code: 6801059 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-1293-2019 · Reported May 15, 2019

    Enforcement

    Recall Number
    Z-1293-2019
    Event ID
    82311
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ortho-Clinical Diagnostics
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 15, 2019
    Initiation Date
    February 20, 2019
    Classification Date
    May 6, 2019
    Termination Date
    September 15, 2021
    Address
    100 Indigo Creek Dr, N/A, Rochester, NY, 14626-5101, United States

    Description

    VITROS ECi Immunodiagnostic System Refurbished Product Code: 6801059 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

    Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems

    Code Info

    Serial Numbers: Systems that had the Luminometer component replaced during a service-repair. UDI: 10758750001040

    Distribution

    Worldwide Distribution: US (Nationwide) and countries of: Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden,The Netherlands, and United Kingdom.

    Quantity

    25 units