Reported Mar 26, 2025 · Ongoing

Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal Antigens, Positive Controls, &…

Immuno-Mycologics, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Immuno-Mycologics, Inc · 2701 Corporate Centre Dr · Norman, OK · 73069-2901

Is this the product you have?

  • 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 codes and dates
  • Lot #:
  • F4171005/UDI00816387020223
Amount recalled
30 vials

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:55 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.