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Wednesday, August 10, 2022
HomeHealth and LifestyleCounterfeit COVID-19 Rapid Antigen Test Kits Found In Ontario

Counterfeit COVID-19 Rapid Antigen Test Kits Found In Ontario

KAWARTHA LAKES-Health Canada is warning residents about counterfeit BTNX Rapid Response COVID-19 antigen rapid test kits (25-pack boxes) found in Ontario.

Health Canada says 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.

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.

Counterfeit health products are imitations of authentic products. Officials say the safety and effectiveness of these counterfeit kits have not been assessed by Health Canada.

After becoming aware of the potential counterfeit kits, Health Canada confirmed with BTNX Inc. that the devices were 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, was sent to Health Canada for compliance follow-up.

Based on information to date, the issue appears to be limited to one manufacturer, Health Advance Inc., and one distributor, Healthful Plus. Health Advance Inc. appears to no longer be manufacturing medical devices and Healthful Plus’s website has been removed and the company appears to no longer be in operation.

COVID-19 rapid antigen tests help to detect infection and slow the spread of the disease. Health 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.

What you should do
  • 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.
  • Health Canada has no evidence to suggest that additional counterfeit kits have been distributed in Canada.
  • If you suspect you have a counterfeit kit, do not use it and dispose of it in household garbage. 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 protected] with the subject line “Suspected Counterfeit BTNX Tests.”
What companies should know
  • It is illegal to sell or advertise counterfeit health products
  • When non-compliance is confirmed by Health Canada, a number of compliance and enforcement options are available to correct non-compliance and mitigate the risk to Canadians including, for example, on-site visits, recalls, public communications, and product seizures. The primary objective of Health Canada’s compliance and enforcement approach is to manage the risks to Canadians using the most appropriate level of intervention.

This table compares the counterfeit vs. authentic BTNX Inc. kits and gives tips for what to look for.

 

Counterfeit BTNX test kit (25-pack)

Authentic BTNX test kit (25-pack)

Counterfeit box (top)

Health Advance name and phone number along with text
“Official Canadian Distributor” and unauthorized text
“Health Canada Approved” appear on box.

Authentic box (top)

Authentic boxes are sealed with a clear sticker with blue
lettering that says “QC APPROVED”.

Counterfeit box (side)

Health Advance name and phone number appear on box.

Authentic box (side)

BTNX Inc. name, address and symbol appear on box.

Counterfeit kits – three open boxes

Each box has varying contents, including varying test
cassettes and assay buffers.

Authentic kit – open box

Shown here: test cassettes, tube stand, assay buffer, swabs,
procedure card and package insert.

Note, assay buffer may come in bottles (shown here) or 25
single-use vials (not shown here).

Not shown here: extraction tubes and nozzle filters

Counterfeit kits – cassette pouch found in some kits

Expiry date and lot number may not match the box. Pouches
are not green.

Authentic kit – box and cassette pouch (back)

Lot number and expiry date on cassette pouch should match the
lot number and expiry date on the box. Lot numbers start with the
letter “I”.

 

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Pamela Vanmeer
Pamela Vanmeerhttps://www.kawartha411.ca/
Pamela VanMeer is a two time winner of the prestigious Radio Television Digital News Association (RTDNA) Award. Her investigative reports on abuse in Long Term Care Homes garnered international attention for the issue and won the Ron Laidlaw Award. She is a former reporter and anchor at CHEX News, now Global Peterborough and helped launch the New CHEX Daily, a daily half hour talk show. While at CHCH News in Hamilton she covered some of the biggest news stories of the day.

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