BEUDAMED
    FDA Enforcement Class II Ongoing

    VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461

    Recall: Z-1676-2022 · Reported September 14, 2022

    Enforcement

    Recall Number
    Z-1676-2022
    Event ID
    90681
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Ortho-Clinical Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 14, 2022
    Initiation Date
    July 19, 2022
    Classification Date
    September 2, 2022
    Address
    100 Indigo Creek Dr, N/A, Rochester, NY, 14626-5101, United States

    Description

    VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461

    Reason

    Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the Digital Imaging Reflectometer. Potential exists for either a positive or negative shift in results reported by the VITROS System.

    Code Info

    UDI-DI: 10758750031610 Systems start with 7600XXXX where XXXX is unique for each analyzer

    Distribution

    Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda DV04, Brazil, Canada L3R 4G5 , Chile, China, Colombia, Denmark, France, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore 609917, Spain, Sweden, The Netherlands, United Kingdom.

    Quantity

    1148 units