Public advisory

Unauthorized blood glucose monitors sold online may pose serious health risks

Last updated

Summary

Product
Unauthorized blood glucose monitors, also referred to as glucose-reading devices or non-invasive glucose monitors
Issue
Health products - Unauthorized product
Medical devices - Inaccurate test or measurement results
What to do

Do not use glucose monitors that have not been authorized by Health Canada. Consult a healthcare professional if you have used an unauthorized glucose monitor and have health concerns. Only use devices listed on Health Canada's Medical Device Active Licence Listing (MDALL).

Affected products

Unauthorized blood glucose monitors, also referred to as glucose-reading devices or non-invasive glucose monitors

Issue

Health Canada is warning people with diabetes and their caregivers that numerous unauthorized blood glucose monitors are being sold through social media and online stores.

Unauthorized products have not been assessed for safety and effectiveness and may pose serious health risks to consumers because they may give false blood glucose readings or may not provide timely alerts, which could lead to errors in diabetes management. Errors may include:

  • taking too little insulin, which can lead to high blood sugar (called hyperglycemia),
  • taking too much insulin, which can lead to low blood sugar (called hypoglycemia), and
  • failing to treat low or high blood sugar.

These errors could lead to serious health consequences requiring medical treatment, such as hyperglycemic emergencies, severely low blood sugar, loss of consciousness, seizures, coma, and death.

These unauthorized devices are being marketed using various descriptions, including glucose-reading devices, blood glucose monitoring systems, non-invasive glucose/health monitors, non-invasive blood glucose meters/monitors, and glucose and vital signs monitors.

While some of these unauthorized devices claim to measure glucose levels non-invasively (without puncturing the skin or inserting a device into the body), consumers should be aware that at this time, Health Canada has not authorized the sale of any non-invasive blood glucose monitoring devices.

In addition, some of the promotional material for these unauthorized products contain false endorsements from Health Canada using its corporate signature. Health Canada does not endorse health products and does not allow its corporate signature to appear on health or consumer product advertising.

Consumers can search Health Canada's Medical Device Active Licence Listing (MDALL) to determine whether a blood glucose monitor has been authorized by the department.

Health Canada will continue to take necessary action to stop the sale and advertising of these unauthorized products in Canada.

What you should do

  • Only use blood glucose monitors that have been authorized by Health Canada.
  • If you suspect that you are using an unauthorized product, stop using it immediately and replace it with an authorized monitor.
  • Talk to your health care provider about which blood glucose monitor is right for you.
  • Only use devices listed on Health Canada's Medical Device Active Licence Listing (MDALL).
  • Report any health product-related side effects or complaints to Health Canada.

Additional information

Details
Original published date:
Alert / recall type
Public advisory
Category
Health products - Medical devices
Companies
Published by
Health Canada
Audience
General public
Identification number
RA-77654
Media and public enquiries

Health Canada
(613) 957-2983
media@hc-sc.gc.ca

Public Enquiries:
(613) 957-2991
1-866 225-0709
info@hc-sc.gc.ca

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