Class II — Potential Health Hazard

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

Cryptococcal Antigen Lateral Flow Assay (CrAg LFA) Recalled by Immuno-Mycologics, Inc Due to The affected products have approximately a 91% specificity...

Date: December 27, 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

Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003

Quantity: 630 units

Why Was This Recalled?

The affected products have approximately a 91% specificity while the non-affected lots have approximately a 99% specificity. The recalling firm is aware of three customers who reported false positive 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