Class II — Potential Health Hazard

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

Histoplasma Immunodiffusion (ID) Antigen Recalled by Immuno-Mycologics, Inc Due to False positive results due to potential contamination of...

Date: November 4, 2019
Company: Immuno-Mycologics, Inc
Status: Terminated
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

Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple products which included Fungal Antigens, Positive Controls and ID Plates,and Immunodiffusion (ID) Plates for use in the ID Test, Histoplasma ID Antigen

Quantity: 155 vials

Why Was This Recalled?

False positive results due to potential contamination of reagent.

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