In an advisory Friday, the federal health agency said the counterfeit products resembled BTNX Inc.’s 25-pack Rapid Response COVID-19 antigen test kits. in color and letters.
Health Canada said the counterfeit kits were sold online by Healthful Plus, which did not have the required 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 have a label on the front that reads “Health Advance Inc.” instead of BTNX. They also have a label with Health Advance as an “Official Canadian Distributor” and have text that says “Canada’s Health Approved”.
“The safety and efficacy of these counterfeit kits have not been evaluated by Health Canada,” the advisory said, adding that the agency has contacted BTNX and confirmed that these kits are 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. appears to no longer manufacture medical devices and the Healthful Plus website has been taken down and The company appears to be defunct.’
Health Canada said the person who purchased the products had confirmed 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 monitoring.
“Heath Canada is notifying the provinces and territories of this issue, as well as medical device licensees, advising them not to purchase from the two companies or distribute further,” the advisory said.
Health Canada noted that there is no evidence to suggest that counterfeit kits have been distributed elsewhere in the country.
Those who purchased test kits from Health Advance Inc. or Healthful Plus are asked not to use them, throw them away and report them to the service.
They can also report it to BTNX Inc. by calling toll-free at 1-888-339-9964 or emailing [email protected] with the subject line “Suspected BTNX Fake Tests.”
