medical Class II Updated 2020-06-17

Immuno-Mycologics, Inc recalls Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling i

Recalled 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


Hazard / Issue

False positive results due to potential contamination of reagent.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot number L106909; UDI # (01) 00816387020391 (17) 220610(10)L106909
View official government recall

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