Health Canada is warning the public about counterfeit rapid antigen test kits after several were sold in Ontario.
In an announcement Friday, the federal health agency said the counterfeit products resembled BTNX Inc.’s rapid response COVID-19 test kits in color and lettering. of 25 packs.
Health Canada said the counterfeit kits were sold online by Healthful Plus, which did not have the necessary license to import, distribute or sell medical devices in the country.
The fake test kits also had BTNX’s device ID “COV-19C25”.
Health Canada said the counterfeit kits had a label on the front that read “Health Advance Inc.” instead of BTNX. They also have a label with Health Advance as “Official Canadian Distributor” and have text that says “Approved by Health Canada”.
“The safety and effectiveness of these counterfeit kits have not been evaluated by Health Canada,” the advisory said, adding that the agency had contacted BTNX and confirmed that the kits were counterfeit.
“Based on information to date, the issue appears to be limited to one manufacturer, Health Advance Inc., and one distributor, Healthful Plus. Health Advance Inc. It appears to no longer manufacture medical devices and the Healthful Plus website has been removed and the company appears to be no longer in business.”
Health Canada said the person who purchased the products confirmed that the kits were for personal use and that all 435 boxes of the 25-pack test kits had been sent to the agency for compliance tracking.
“Heath Canada is informing the provinces and territories of this issue, as well as medical device establishment license holders, advising them not to purchase from either company or distribute further,” it said.
Health Canada noted that there is no evidence to suggest that counterfeit kits have been distributed elsewhere in the country.
Those who have purchased test kits from Health Advance Inc. or Healthful Plus, are asked not to use them, throw them away and report them to the agency.
They can also report it to BTNX Inc. by calling toll-free at 1-888-339-9964 or emailing covid19@btnx.com with the subject line “Suspected false BTNX tests.”
Add Comment