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 25-pack Rapid Response COVID-19 antigen raid test kits in color and lettering.
Health Canada said the fake 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 identifier ‘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 the “Official Canadian Distributor” and have text that reads “Health Canada Approved.”
“The safety and effectiveness of these counterfeit kits have not been assessed 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 problem 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 Healthful Plus’ website has been taken down , and the company appears to be no longer in business.”
Health Canada said the person who purchased the products had confirmed that the kits were for personal use and that all 435 boxes of 25-pack test kits had been sent to the agency for compliance follow-up.
“Heath Canada is informing the provinces and territories of this issue, as well as Medical Device Establishment License holders, and advising them not to purchase from the two companies or redistribute,” the release said.
Health Canada noted that there is no indication 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, dispose of them 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 email@example.com with the subject line “Suspected Counterfeit BTNX Tests.”