Reported Jun 17, 2020 · Terminated

Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple products which included Fungal Antigens,…

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 · 2700 Technology Pl · Norman, OK · 73071-1127

Is this the product you have?

  • Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple products which included Fungal Antigens, Positive Controls and ID Plates,and Immunodiffusion (ID) Plates for use in the ID Test, Histoplasma ID Antigen
Lot codes and dates
  • Lot number L106909; UDI # (01) 00816387020391 (17) 220610(10)L106909
Amount recalled
155 vials

Where it was sold

Why it was recalled

False positive results due to potential contamination of reagent.

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

Notice updated May 27, 2022 · Data as of Sep 19, 5:27 PM UTC

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