BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated February 10, 2025

    Recall

    Recall Number
    Z-1389-2025
    Event Number
    96315
    Firm
    Immuno-Mycologics, Inc
    FEI Number
    1627497
    Product Code
    GMI
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    February 10, 2025
    Posted
    March 18, 2025
    Address
    2701 Corporate Centre Dr, Norman, OK, 73069-2901

    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.

    Action

    On February 10, 2025, Immy issued a "Urgent Medical Device Recall" Notification to affected consignees. Immy asked consignees to take the following actions: 1. Immediately identify, count, and segregate any affected vials you have in your inventory to prevent them from being used or shipped to your customers. As soon as possible, discard your affected inventory. 2. Complete the attached Acknowledgement and Receipt Form (pages 3 and 4 below) even if you do not have any affected stock remaining in your possession. Note: The form is a fillable PDF. You can save it to your computer, fill out electronically and attach to an email. Return the completed form to IMMY using one of the methods below: o Email: [email protected]; Mail to: Attn: Hunter Conover IMMY, Inc., 2701 Corporate Centre Dr., Norman, OK USA 73069 3. Ensure relevant staff members are informed of this recall, including relevant clinicians. Clinicians should review all negative results. 4. If you have supplied any potentially affected product to another organization, please advise that organization of this recall and send them this notification. Please contact us so we can follow up with them. 5. In case product is in transit, display this letter in a prominent place for one month.

    Distribution

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

    Quantity

    30 vials