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 Yeast Complement Fixation Antigen Dilute Ref# H30150 The fungal Recalled by Immuno-Mycologics, Inc Due to The device was found to have bacterial contamination.

Date: May 9, 2016
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 Yeast Complement Fixation Antigen Dilute Ref# H30150 The fungal antigens and positive controls are used to detect antibodies in patient serum by the complement fixation (CF) procedure to aid in the diagnosis of four specific fungal diseases: Histoplasmosis, blastomycosis, coccidioidomycosis, and aspergillosis

Quantity: 467 units

Why Was This Recalled?

The device was found to have bacterial contamination.

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