Health Canada is warning the public against counterfeit rapid antigen test kits after several were sold in Ontario.
In a notice issued Friday, the federal health agency said the counterfeit products resembled BTNX Inc.’s 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 required license to import, distribute or sell medical devices in the country.
The fake test kits also carried BTNX’s device identifier “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 the “Official Canadian Distributor” and text that says “Approved by Health Canada”.
“The safety and effectiveness of these counterfeit kits have not been evaluated by Health Canada,” the notice states, adding that the agency has contacted BTNX and confirmed that these kits are fake.
“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 deleted and the business appears to no longer be in operation.”
Health Canada said the person who purchased the products confirmed the kits were for personal use and that all 435 boxes of the 25-pack test kits were sent to the agency for compliance tracking.
“Heath Canada is advising provinces and territories of this issue, as well as Medical Device Establishment Licensees, advising them not to purchase from both companies or to distribute further,” the notice reads.
Health Canada noted that there is no evidence to suggest counterfeit kits have been distributed anywhere else in the country.
Those who purchased test kits from Health Advance Inc. or Healthful Plus are urged not to use them, discard 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 protected] with the subject line “Suspected Counterfeit BTNX Tests”.