FDA-Device2020-06-17Class II
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
Immuno-Mycologics, Inc
Hazard
False positive results due to potential contamination of reagent.
Sold states
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.
Affected count
155 vials
Manufactured in
2700 Technology Pl, N/A, Norman, OK, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2301-2020Don't want to check this manually?
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