Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Candida ID Antigen Recalled by Immuno-Mycologics, Inc Due to Candida Immunodiffusion Antigen may have reduced sensitivity which...

Date: February 10, 2025
Company: Immuno-Mycologics, Inc
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Immuno-Mycologics, Inc directly.

Affected Products

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

Quantity: 30 vials

Why Was This Recalled?

Candida Immunodiffusion Antigen may have reduced sensitivity which could result in false negative results.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Immuno-Mycologics, Inc

Immuno-Mycologics, Inc has 6 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report