Immuno-Mycologics, Inc: Medical Device Recall in 2025 - (Recall #: Z-1389-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 10, 2025

Date Posted: March 26, 2025

Recall Number: Z-1389-2025

Event ID: 96315

Reason for Recall:

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

Status: Ongoing

Product Quantity: 30 vials

Code Information:

Lot #: F4171005/UDI: 00816387020223

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated