BEUDAMED
    FDA Enforcement Class II Ongoing

    VITROS Immunodiagnostic Products - TSH Reagent Pack (10758750000227) 1912997

    Recall: Z-0061-2019 · Reported October 10, 2018

    Enforcement

    Recall Number
    Z-0061-2019
    Event ID
    80717
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Ortho Clinical Diagnostics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 10, 2018
    Initiation Date
    July 12, 2018
    Classification Date
    October 3, 2018
    Address
    1001 US Highway 202, Raritan, NJ, 08869-1424, United States

    Description

    VITROS Immunodiagnostic Products - TSH Reagent Pack (10758750000227) 1912997

    Reason

    The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations which are lower than indicated in the current Instructions For Use (IFU). Patients who are taking biotin supplements could potentially have biased sample results for affected assays at biotin concentrations lower than indicated in the current IFU.

    Code Info

    5535 5540 5550 5560 5570 5580 5590 5600 5610 5615 5620 5630 5640 5650 5655 5660 5665 5670 5675 5678 5680 5685 5690

    Distribution

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

    Quantity

    68230