FDA Medical devices recall ·
Candida ID Antigen, REAG, AG recall
- Recall number
- Z-1389-2025
- Date
- (initiated February 10, 2025)
- Company / brand
- Immuno-Mycologics, Inc
2701 Corporate Centre Dr, Norman, OK, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 30 vials
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
Candida Immunodiffusion Antigen may have reduced sensitivity which could result in false negative results.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: F4171005/UDI: 00816387020223
Distribution
Worldwide - US Nationwide distribution in the states of CA and OK and the countries of Peru France, Austria, Venezuela.
States: California Oklahoma
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1389-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.