BEUDAMED
    FDA Enforcement Class II Ongoing

    Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal Antigens, Positive Controls, & Immunodiffusion (ID) plates for use in the ID test, RX only, IVD, CE

    Recall: Z-1389-2025 · Reported March 26, 2025

    Enforcement

    Recall Number
    Z-1389-2025
    Event ID
    96315
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Immuno-Mycologics, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 26, 2025
    Initiation Date
    February 10, 2025
    Classification Date
    March 18, 2025
    Address
    2701 Corporate Centre Dr, N/A, Norman, OK, 73069-2901, United States

    Description

    Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal Antigens, Positive Controls, & Immunodiffusion (ID) plates for use in the ID test, RX only, IVD, CE

    Reason

    Candida Immunodiffusion Antigen may have reduced sensitivity which could result in false negative results.

    Code Info

    Lot #: F4171005/UDI: 00816387020223

    Distribution

    Worldwide - US Nationwide distribution in the states of CA and OK and the countries of Peru France, Austria, Venezuela.

    Quantity

    30 vials