Immuno-Mycologics, Inc recalls Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal Antigens, Positive Controls, & Immunodiffusi…

Recall date

February 10, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1389-2025

FDA classification

Class II

Brand / firm

Immuno-Mycologics, Inc

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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