BEUDAMED
    FDA Enforcement Class III Ongoing

    VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use only.VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated System - Product Code: 8231474

    Recall: Z-0471-2021 · Reported November 25, 2020

    Enforcement

    Recall Number
    Z-0471-2021
    Event ID
    86669
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Ortho Clinical Diagnostics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 25, 2020
    Initiation Date
    October 16, 2020
    Classification Date
    November 18, 2020
    Address
    1001 US Highway 202, N/A, Raritan, NJ, 08869-1424, United States

    Description

    VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use only.VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated System - Product Code: 8231474

    Reason

    Product instability; biased ALKP values obtained from VITROS Chemistry Products Performance Verifier II Lot Q7692 when stored unopened at refrigerated temperatures

    Code Info

    Lot Q7692 , EXP: 01-NOV-2021 UDI: 10758750004577

    Distribution

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

    Quantity

    10788 total: US 4680; OUS 6108