Counterfeit COVID-19 rapid antigen tests have been found in Ontario, Health Canada has announced, urging the public to be cautious.
“The packaging of the counterfeit kits resembles genuine (licensed) BTNX Inc. products in color and lettering, and uses the BTNX Inc identifier ‘COV-19C25’,” the statement said. federal agency.
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 no longer appears to be in business.
If you suspect you have a counterfeit kit, don’t use it and throw it away. Remember to report to Health Canada when you believe 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 and the
- text “Official Canadian Distributo” and unauthorized text “Health Canada Approved” appear on the box.
- On the side of the counterfeit box is 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 cassette packaging pouches, the expiration date and lot number may not match those on the box and the pouches are not green.
Here’s how to recognize an authentic kit:
- 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.
- Authentic 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.
- 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”.