Epoc Blood Analysis System - Computing Device With Custom Software (2019-06-11)

EPOC Blood Analysis System Recall The EPOC Blood Analysis System, a computing device used for blood testing, has been recalled across Canada. The device is being recalled because it is classified as a medical device that does not meet regulatory requirements. This recall affects all EPOC Blood Analysis Systems distributed in Canada.

Reason
Medical devices
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2019-06-28
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/4020b725-6e14-4dc3-945c-651ab49c9125