Rchitect Igentamicin Reagent Kit (2020-04-28)

Recall Summary The ARCHITECT iGentamicin Reagent Kit is being recalled across Canada because it is a medical device that does not meet regulatory requirements. This is classified as a Class I recall, which indicates a serious issue. The recall affects all units of this product that were distributed in Canada.

Reason
Medical devices
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2020-05-08
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/5c1d4012-86ff-4367-a428-25bc3af777dc