Immuno-Mycologics, Inc: Device Recall
Recall #Z-1389-2025 · 02/10/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1389-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Immuno-Mycologics, Inc
- Status
- Ongoing
- Date Initiated
- 02/10/2025
- Location
- Norman, OK, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30 vials
Reason for Recall
Candida Immunodiffusion Antigen may have reduced sensitivity which could result in false negative results.
Product 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
Distribution Pattern
Worldwide - US Nationwide distribution in the states of CA and OK and the countries of Peru France, Austria, Venezuela.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.