BEUDAMED
    FDA Enforcement Class II Ongoing

    VITROS 5600 Integrated System (New and Refurbished)

    Recall: Z-1221-2024 · Reported March 13, 2024

    Enforcement

    Recall Number
    Z-1221-2024
    Event ID
    93892
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Ortho-Clinical Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 13, 2024
    Initiation Date
    January 22, 2024
    Classification Date
    March 1, 2024
    Address
    100 Indigo Creek Dr, Rochester, NY, 14626-5101, United States

    Description

    VITROS 5600 Integrated System (New and Refurbished)

    Reason

    Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems which may lead to erroneous test results.

    Code Info

    UDI/DI: (New) 10758750002740, (Refurbished) 10758750007110; Serial Numbers: J56000280, J56000330, J56000415, J56000631, J56000634, J56000721, J56000839, J56000871, J56001088, J56001209, J56001228, J56001265, J56001305, J56001355, J56001834, J56001855, J56001941, J56001998, J56002111, J56002239, J56002476, J56002492, J56002531, J56002561, J56002649, J56002655, J56002658, J56002691 and J36001164 through J36001692 (inclusive).

    Distribution

    Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, United Kingdom.

    Quantity

    1460 units (506 US, 954 OUS)