BEUDAMED
    FDA Enforcement Class II Terminated

    Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 - Product Usage: intended for the qualitative detection of Measles igM antibodies in human serum of patients suspected of measles (rubeola) infection.

    Recall: Z-1503-2021 · Reported May 5, 2021

    Enforcement

    Recall Number
    Z-1503-2021
    Event ID
    87637
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Clark Laboratories, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 5, 2021
    Initiation Date
    March 17, 2021
    Classification Date
    April 27, 2021
    Termination Date
    June 29, 2022
    Address
    2823 Girts Rd, N/A, Jamestown, NY, 14701-9666, United States

    Description

    Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 - Product Usage: intended for the qualitative detection of Measles igM antibodies in human serum of patients suspected of measles (rubeola) infection.

    Reason

    Positive Control may run high out of its assigned ISR range and result in an invalid run and necessitate retesting

    Code Info

    Kit Lot: 2326060-060 Expiration Date: 2021-06-28 (UDI): 05391516743655

    Distribution

    Worldwide distribution - US Nationwide distribution and the country of Ireland.

    Quantity

    80 kits