BEUDAMED
    FDA Enforcement Class II Terminated

    VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control - Product Usage: For use in monitoring the performance of the VITROS Immunodiagnostic and Integrated Systems when used for the determination of IgG antibodies to SARS-CoV-2. Product Code (Unique Identifier): 6199921 (10758750033355)

    Recall: Z-0451-2021 · Reported November 25, 2020

    Enforcement

    Recall Number
    Z-0451-2021
    Event ID
    86573
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ortho Clinical Diagnostics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 25, 2020
    Initiation Date
    September 30, 2020
    Classification Date
    November 13, 2020
    Termination Date
    December 7, 2023
    Address
    1001 US Highway 202, N/A, Raritan, NJ, 08869-1424, United States

    Description

    VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control - Product Usage: For use in monitoring the performance of the VITROS Immunodiagnostic and Integrated Systems when used for the determination of IgG antibodies to SARS-CoV-2. Product Code (Unique Identifier): 6199921 (10758750033355)

    Reason

    Elevated sample results signal/cutoff (s/c) values when using eight (8) lots of VITROS immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator and decreased signal in one (1) lot of VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control

    Code Info

    Lot Number/ Exp. Date: 0110 25-NOV-20

    Distribution

    Worldwide distribution - US Nationwide distribution and the countries of Australia, Brazil, Chile, China, Colombia, India, Japan, Singapore 609917, United Kingdom, Italy.

    Quantity

    691 units (OUS)