FDAClass IIMarch 26, 2025

Candida ID Antigen 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…

Why was Candida ID Antigen recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: F4171005/UDI: 00816387020223

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…
Recalling firm
Immuno-Mycologics, Inc
Quantity
30 vials
Distribution
Worldwide - US Nationwide distribution in the states of CA and OK and the countries of Peru France, Austria, Venezuela.
Recall date
March 26, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls