The agency says the counterfeit tests were sold online in 25-pack boxes by a distributor called Healthful Plus without the required licence.
It says the packaging resembles authentic products by BTNX Inc. and uses the device identifier “COV-19C25,” but also has several key differences.
Those include the manufacturer being listed as Health Advance Inc. rather than BTNX Inc.; Health Advance being listed as an “official Canadian distributor”; and the addition of the text “Health Canada approved” on the box.
Health Canada says it has not assessed the safety and effectiveness of the counterfeit kits.
The agency says anyone who suspects they have a counterfeit kit should refrain from using it and instead report it, either to the government or to BTNX.
Health Canada says the issue appears to be limited to one manufacturer, Health Advance Inc., and one distributor, Healthful Plus. It says Health Advance appears to no longer be making medical devices and Healthful Plus’s website has been taken down.