Health Canada is warning the public about counterfeit rapid antigen test kits after several were sold in Ontario.
In an advisory on 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 required 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 in front that reads “Health Advance Inc.” instead of BTNX. They also have a label with Health Advance as the “Official Canadian Distributor” and have a text that reads “Health Canada Approved.”
“The safety and effectiveness of these counterfeit kits have not been assessed by Health Canada,” the advisory stated, 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 be manufacturing medical devices and Healthful Plus’s website has been removed and the company appears to no longer be in operation.”
Health Canada said the person who purchased the products had 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 follow-up.
“Heath Canada is informing the provinces and territories about this issue, as well as Medical Device Establishment License holders, advising them to not purchase from the two companies or further distribute,” the advisory stated.
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, 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 protected] with the subject line “Suspected Counterfeit BTNX Tests.”