Counterfeit COVID-19 rapid antigen tests have been found in Ontario, Health Canada announced, urging the public to be cautious.
“The packaging of the kits counterfeit products resemble genuine (licensed) BTNX Inc. products in color and lettering, and use BTNX Inc's identifier “COV-19C25,” the federal agency said.
As these products have not been approved by Health Canada, their effectiveness has not been evaluated.
“Based on the information we have to date, the issue appears to be limited to one manufacturer, Health Advance Inc., and one distributor, Healthful Plus. Health Advance Inc. no longer appears to manufacture devices, the Healthful Plus website has been taken offline, and the company appears to no longer be in business,” it said.
If you suspect you have a counterfeit kit, do not don't use it and throw it away. Don't forget to report to Health Canada when you think you have a counterfeit medical device.
Here's how to recognize counterfeit kits:
- On the top of the counterfeit box is Health Advance's name and phone number along with the
- text “Official Canadian Distributo” and the unauthorized text “Health Canada Approved” on the box.
- The side of the counterfeit box has Health Advance's name and phone number.
- Counterfeit kits have 3 open boxes. The contents vary for each box, including its various test cassettes and vials of buffer solution.
- On the packaging bags of the cassette, the expiration date and the lot number may not match those on the box and the pouches are not green.
Here's how to recognize an authentic kit:
- The Genuine boxes are sealed with a clear sticker that says “QC APPROVED” in blue.
- The name, address and symbol of BTNX Inc. are on the side of the box.
- Genuine kits feature a single open box. In these boxes there are test cassettes, a tube rack, vials of buffer solution, swabs, a procedure card, a pharmaceutical leaflet as well as extraction tubes and tips with filters.
< li>The lot number and expiration date on the cassette pouch should match the lot number and expiration date on the box. Batch numbers beginning with the letter “I”.