Health Canada has issued a warning about counterfeit COVID-19 rapid test kits found in Ontario.
The kits, which were sold online by a distributor without proper licences, are counterfeits of the BTNX Rapid Response COVID-19 antigen rapid test kits (25-pack boxes), and the distributor Healthful Plus did not have the licence to import, distribute or sell medical devices in Canada.
"The packaging of the counterfeit kits resembles authentic (licensed) BTNX Inc. products in colour and typeface and uses the BTNX Inc. device identifier 'COV-19C25'," reads Health Canada's statement.
But unlike authentic BTNX kits, the counterfeit kits are labelled as manufactured by "Health Advance Inc." instead of BTNX Inc., while listing Health Advance as an "Official Canadian Distributor." They also include the text "Health Canada Approved," even though claims of endorsement by government authorities are not permitted.
Other tips for spotting counterfeit kits include the fact that authentic boxes are sealed with a clear sticker with blue lettering that says "QC APPROVED" and counterfeit boxes have varying contents. The lot number (starting with the letter 'I') and expiry date on the green cassette pouch should also match the lot number and expiry date on the box.
"The safety and effectiveness of these counterfeit kits have not been assessed by Health Canada," said Health Canada.
The entire shipment containing 435 boxes of potential counterfeit kits has been sent to Health Canada for compliance follow-up.
Health Canada said there is no evidence to suggest additional counterfeit kits have been distributed in Canada; however, those suspecting they might have a counterfeit kit should not use it and should instead dispose of it in household garbage.
Suspected counterfeit medical devices can be reported to Health Canada through online forms. Counterfeit BTNX test kits can also be reported to BTNX Inc. by calling toll-free at 1-888-339-9964, or by email at firstname.lastname@example.org with the subject line "Suspected Counterfeit BTNX Tests."