BEUDAMED
    FDA Enforcement Class II Terminated

    Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple products which included Fungal Antigens, Positive Controls and ID Plates,and Immunodiffusion (ID) Plates for use in the ID Test, Histoplasma ID Antigen

    Recall: Z-2301-2020 · Reported June 17, 2020

    Enforcement

    Recall Number
    Z-2301-2020
    Event ID
    85368
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Immuno-Mycologics, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 17, 2020
    Initiation Date
    November 4, 2019
    Classification Date
    June 9, 2020
    Termination Date
    May 27, 2022
    Address
    2700 Technology Pl, N/A, Norman, OK, 73071-1127, United States

    Description

    Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple products which included Fungal Antigens, Positive Controls and ID Plates,and Immunodiffusion (ID) Plates for use in the ID Test, Histoplasma ID Antigen

    Reason

    False positive results due to potential contamination of reagent.

    Code Info

    Lot number L106909; UDI # (01) 00816387020391 (17) 220610(10)L106909

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of AZ, CA, FL, IL, IN, MI, MN, NY,TX, UT, VA, WI and the countries of France, Spain, Hong Kong, United Kingdom.

    Quantity

    155 vials