Id- Fungal Antibody System - Histoplasma (2019-11-06)

Recall Summary The ID-Fungal Antibody System for Histoplasma, a medical device used to detect fungal infections, has been recalled across Canada. The device was recalled due to concerns related to its classification as a medical device. This recall affects healthcare facilities and laboratories that use this diagnostic system.

Reason
Medical devices
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2019-11-29
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/d50e9f95-c8c3-4b06-b2bf-f61e410d4043