# FDA recall Z-1389-2025

> **Immuno-Mycologics, Inc** · Class II · device recall initiated 2025-02-10.

## 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.

## Distribution

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

## Key facts

- **Recall number:** Z-1389-2025
- **Recalling firm:** Immuno-Mycologics, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-02-10
- **Report date:** 2025-03-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Norman, OK, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1389-2025

## Citation

> AI Analytics. FDA recall Z-1389-2025. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1389-2025. Source: US FDA. Licensed CC0.

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