Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal Antigens, Positive Controls, & Immunodiffu
Summary
The FDA issued a Class II for Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal An by Immuno-Mycologics, Inc. Reason: Candida Immunodiffusion Antigen may have reduced sensitivity which could result in false negative results..
Details
Source
Device Recall
External ID
Z-1389-2025
Action Date
2025-03-26
Status
Ongoing
Category
device
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
Lot/Code Info: Lot #: F4171005/UDI: 00816387020223
Quantity Affected: 30 vials
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-02-10
Company
Norman, OK
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 195 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Immuno-Mycologics, Inc has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Immuno-Mycologics, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Immuno-Mycologics, Inc have FDA actions?
Immuno-Mycologics, Inc has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1389-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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