BEUDAMED
    FDA Enforcement Class III Terminated

    VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468

    Recall: Z-1834-2020 · Reported May 6, 2020

    Enforcement

    Recall Number
    Z-1834-2020
    Event ID
    85298
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ortho Clinical Diagnostics
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 6, 2020
    Initiation Date
    March 10, 2020
    Classification Date
    April 30, 2020
    Termination Date
    September 26, 2022
    Address
    100 Indigo Creek Dr, N/A, Rochester, NY, 14626-5101, United States

    Description

    VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468

    Reason

    The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations.

    Code Info

    UDI: 10758750005147; Lot Number: 2340

    Distribution

    US Nationwide. Australia, Bermuda, Belgium, Brazil, Canada, Chile, China, Columbia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, UK.

    Quantity

    3181