FDA recall Z-1389-2025

Immuno-Mycologics, Inc · Class II · device

Product

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

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.

Key facts

Status
Ongoing
Initiation date
2025-02-10
Report date
2025-03-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Norman, OK, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1389-2025