Class II

Medical Device Recall: 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

Immuno-Mycologics, Inc · February 10, 2025

Reason for Recall

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

Distribution

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

States Affected

NATIONWIDE

Quantity Affected

30 vials

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1389-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Immuno-Mycologics, Inc Medical Device Recall: 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 | SafeCheck