BEUDAMED
    FDA Enforcement Class II Terminated

    VITROS XT3400 Chemistry System, Product code 6844458

    Recall: Z-2878-2020 · Reported September 2, 2020

    Enforcement

    Recall Number
    Z-2878-2020
    Event ID
    86096
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ortho Clinical Diagnostics
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 2, 2020
    Initiation Date
    July 20, 2020
    Classification Date
    August 24, 2020
    Termination Date
    December 18, 2023
    Address
    100 Indigo Creek Dr, N/A, Rochester, NY, 14626-5101, United States

    Description

    VITROS XT3400 Chemistry System, Product code 6844458

    Reason

    When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be mis-positioned. As a result, certain VITROS MicroSlides may produce erroneous results.

    Code Info

    Serial numbers J34500122 J34500231

    Distribution

    Worldwide distribution - US Nationwide distribution and the 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, United Kingdom.

    Quantity

    pending