(The side of the counterfeit box showing the Health Advance name and phone number that appear on box. Photos: Health Canada)
Health Canada is warning consumers about counterfeit BTNX Rapid Response COVID-19 antigen rapid test kits (25-pack boxes) that have been found in Ontario.
The counterfeit devices were sold online by a distributor named Healthful Plus, without the required licence to import, distribute or sell medical devices in Canada, Health Canada said in its warning which shows the differences between the authentic and counterfeit products.
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”; however, unlike authentic BTNX Inc. products, the counterfeit kits:
- are labelled as manufactured by “Health Advance Inc.” instead of BTNX Inc.;
- lists Health Advance as an “Official Canadian Distributor”; and,
- includes the text “Health Canada Approved”. Claims of endorsement by government authorities, such as Health Canada, are not permitted.
The warning states, “Counterfeit health products are imitations of authentic products. The safety and effectiveness of these counterfeit kits have not been assessed by Health Canada.”.
Health Canada has confirmed with BTNX Inc. that the devices are counterfeit. Health Canada also received confirmation from the purchaser of the counterfeit products that they had purchased the kits for personal use. The entire shipment, which contained 435 boxes of the 25-pack, were sent to Health Canada for compliance follow-up.
Health Canada further stated, “COVID-19 rapid antigen tests are an essential tool in helping to detect infection and slow the spread of the disease. Health Canada recognizes that it is vital that Canadians can trust that the test kits that they rely on are authentic. 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.”
Canadians are advised not to use any of the components contained in these counterfeit kits regardless of how much they may resemble components found in other licensed COVID-19 test kits sold in Canada.
Report suspected counterfeit medical devices to Health Canada. You can also report suspected counterfeit BTNX test kits to BTNX Inc. by calling toll-free at 1-888-339-9964, or by email at email@example.com with the subject line “Suspected Counterfeit BTNX Tests.”