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Immuno-Mycologics, Inc recalls Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple products which included Fungal Antigens, Posi
Recalled June 17, 2020 · FDA recall Z-2301-2020 · Immuno-Mycologics
Hazard
False positive results due to potential contamination of reagent. · FDA Class II
Units
155 vials
Sold at
Worldwide distribution - US Nationwide distribution including in the states of AZ, CA, FL, IL, IN, MI, MN, NY,TX, UT, VA, WI and the countries of France, Spain, Hong Kong, United Kingdom.
Description
False positive results due to potential contamination of reagent.
Product
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
Manufacturer(s)
Immuno-Mycologics, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →