Immuno-Mycologics, Inc recalls Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple products which included Fungal Antigens, Pos…

Recall date

November 4, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2301-2020

FDA classification

Class II

Brand / firm

Immuno-Mycologics, Inc

Sold / distributed

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.

Why it was recalled

False positive results due to potential contamination of reagent.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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