BEUDAMED
    FDA Enforcement Class II Terminated

    The ImmunoCard Mycoplasma EIA detects the presence of IgM to M. pneumoniae in serum - Product Usage: intended to aid in the diagnosis of recent Mycoplasma pneumoniae infection.

    Recall: Z-1299-2021 · Reported March 31, 2021

    Enforcement

    Recall Number
    Z-1299-2021
    Event ID
    87430
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Meridian Bioscience Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 31, 2021
    Initiation Date
    February 8, 2021
    Classification Date
    March 24, 2021
    Termination Date
    October 26, 2021
    Address
    3471 River Hills Dr, N/A, Cincinnati, OH, 45244-3023, United States

    Description

    The ImmunoCard Mycoplasma EIA detects the presence of IgM to M. pneumoniae in serum - Product Usage: intended to aid in the diagnosis of recent Mycoplasma pneumoniae infection.

    Reason

    Use of the kits after incorrect storage could lead to a potential false-negative or invalid result. In the event of a false-negative, the incorrect assumption would be made as to the cause of patient symptoms. The appropriate treatment may not be administered, and symptoms may progress. Additional evaluations will be completed and documented within the associated Health Hazard Evaluation.

    Code Info

    Catalog Number: 709030, Lot Number: 709030M114, Device Identifier: 00840733101762.

    Distribution

    US Nationwide distribution in the states of OH, SC.

    Quantity

    8 kits