Candida ID Antigen — Class II medical device recall Z-1389-2025
Ongoing recall by Immuno-Mycologics, Inc, reported 2025-03-26, distributed nationwide. Candida Immunodiffusion Antigen may have reduced sensitivity which could result in false negative results.
| Recall number | Z-1389-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Immuno-Mycologics, Inc, Norman, OK, United States |
| Recall initiated | 2025-02-10 |
| Classified | 2025-03-18 |
| Reported by FDA | 2025-03-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, FR, PE, VE |
| Quantity | 30 vials |
| UPC / GTIN / UDI-DI | 00816387020223 |
| Lot numbers | F4171005 |
| Model numbers | C50110, ID1001 |
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
Reason for recall
Candida Immunodiffusion Antigen may have reduced sensitivity which could result in false negative results.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1389-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.