Unauthorized test kits claiming to diagnose or detect COVID-19 put your health at risk

Starting date:

May 7, 2020

Posting date:

May 7, 2020

Type of communication:

Advisory

Subcategory:

Medical Device

Source of recall:

Health Canada

Issue:

Unauthorized products, Quality

Audience:

General Public

Identification number:

RA-73003

Last updated: 2020-06-15

Summary

• Product:
  Test kits, including sample collection kits, claiming to diagnose or detect COVID-19.
• Issue:
  Health Canada is warning Canadians of the risks of purchasing unauthorized test kits to diagnose or detect COVID-19.
• What to do:
  If you have purchased an unauthorized test kit that claims to diagnose or detect COVID-19, do not use it or rely on its results. Consult your local health authority for recommendations on testing and testing services for COVID-19. If you have any information on the potential false or misleading advertising or sale of products that have not been authorized by Health Canada, report it.

• 
  Issue
• 
  What you should do
• 
  Media enquiries
• 
  Public enquiries

Issue

OTTAWA – Health Canada is warning Canadians not to buy home diagnostic test kits, including mail-in sample collection kits, claiming to diagnose or detect COVID-19 because they may provide inaccurate or false results. These products have not been authorized by Health Canada, which means they have not been reviewed for safety, quality or effectiveness.

Health Canada has authorized COVID-19 test kits intended for use only by healthcare professionals or trained operators.

The Department continues to monitor websites for false claims and is working with online retailers to ensure that unauthorized COVID-19 diagnostic or detection test kits are removed from their websites.

Health Canada is also working with the RCMP to take action when unauthorized test kits are found to be sold in Canada, including a recent seizure of over 1500 test kits in B.C.

Selling or advertising health products that make false or misleading claims is illegal in Canada. The Department takes this issue seriously and will use all mechanisms and tools at its disposal to stop these activities.

What you should do

• If you have purchased a test kit that claims to diagnose or detect COVID-19, do not use it or rely on its results. Consult a healthcare professional if you have any concerns.
• If you think you may have symptoms of COVID-19, take an online self-assessment or call your local public health authority.
• Your local public health authority can provide recommendations on locations for testing and testing services for COVID-19.
• If you have any information on potential false and misleading advertising or the sale of products that have not been authorized by Health Canada, report it.
• Read the information Health Canada has posted on the risks of buying drugs, natural health products or medical devices online if you are considering buying health products over the Internet.
• Report any health product adverse events to Health Canada.

Media enquiries

Health Canada

(613) 957-2983
hc.media.sc@canada.ca

Public enquiries

(613) 957-2991

1-833-784-4397
hcinfo.infosc@canada.ca