Device evidence

device-recall:cfres:180696

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 recall number

Z-2301-2020

Evidence summary

Product code: GMJ
Recall status: Terminated
Event initiated: November 04, 2019
Root cause: Under Investigation by firm
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-2301-2020