Fake rapid COVID-19 antigen tests have been found in Ontario, Health Canada has announced, urging the public to exercise caution.
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“The packaging of the counterfeit kits is similar in color and lettering to genuine (licensed) BTNX Inc. products and uses the BTNX Inc identifier ‘COV-19C25,'” the federal agency’s statement said.
Because these products are not approved by Health Canada, their effectiveness has not been evaluated.
“Based on the information we have to date, the issue appears to be isolated to one manufacturer, Health Advance Inc., and one distributor, Healthful Plus. Health Advance Inc. appears to have stopped manufacturing devices, the Healthful Plus website has gone offline and the company appears to be out of business.
If you suspect you have a counterfeit kit, do not use it and throw it away. Remember to report Health Canada if you think you have a counterfeit medical device.
How to spot counterfeit kits:
- At the top of the fake box is Health Advance’s name and phone number and the
- Text “Official Canadian Distributo” and unauthorized text “Health Canada Approved” appear on the packaging.
- On the side of the counterfeit box is Health Advance’s name and phone number.
- Fake kits have 3 open boxes. The contents vary for each box, including the different test cassettes and vials of buffer solution.
- The expiration date and lot number on the cassette packaging pouches may not match those on the box and the pouches are not green.
How to recognize an authentic kit:
- Original packages are sealed with a clear sticker that says “QC APPROVED” in blue.
- The BTNX Inc. name, address and symbol are on the side of the box.
- Authentic kits feature a single open box. These boxes contain test cassettes, a tube rack, vials of buffer solution, swabs, a procedural card, a package insert, and extraction tubes and tips with filters.
- The lot number and expiration date on the cassette pouch should match the lot number and expiration date on the box. Lot numbers beginning with the letter “I”.