Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1389-2025 — 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

U.S. FDA — Device Enforcement · United States · 2025-02-10 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1389-2025
Date of alert
2025-02-10
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Immuno-Mycologics, Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00816387020223
Reported risk: Candida Immunodiffusion Antigen may have reduced sensitivity which could result in false negative results.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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