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Unlicensed HIV Home Test Kit: Accu-HIV 1 & 2 Saliva

Advisory
September 16, 2011

The issue:

Following information that a Toronto Company, ACCU-METRICS, has been advertising HIV home test kits for sale via their website, Health Canada would like to remind Canadians that there are currently no HIV test kits that have been authorized for home use in Canada.

The Accu-HIV 1 & 2 Saliva Test, or any other HIV home test kits, have not been evaluated by Health Canada for safety and effectiveness. Inaccurate test results from unlicensed HIV test kits may provide Canadians with false test results, such as a failure to indicate HIV in an infected individual, or indicate HIV when none is present.

Who is affected:

Canadians who have purchased HIV home test kits.

What consumers should do:

  • Consult your healthcare practitioner if you have used any HIV home test kits and/or are concerned about your health.
  • Report any complaints potentially related to HIV home test kits to Health Canada(see below).

What Health Canada is doing:

ACCU-METRICS has voluntarily complied with Health Canada's instructions that this product will not be sold to Canadians via their website. It is illegal to advertise or sell unlicensed medical devices in Canada. In addition, Health Canada officials have also alerted our international partners about Accu-HIV 1 & 2 Saliva Test available via the Internet.

For more information on home test kits, please visit Health Canada's It's Your Health articles on Medical Test Kits for Home Use and Buying Medical Devices over the Internet . For more information on HIV and how you can protect yourself, Health Canada has also published an It's Your Health article on HIV/AIDS .To confirm whether a device is licensed in Canada, please refer to the Medical Devices Active Licence Listing .

Health Canada will continue to monitor the situation and will take appropriate action and inform Canadians,if necessary.

Products affected:

Accu-HIV 1 & 2 Saliva Test

For more information:

Consumers and health professionals wanting more information about this advisory from Health Canada can contact the Public Enquiries Line at 613-957-2991, or toll free at1-866-225-0709.

Media enquiries related to this Advisory should be directed to Health Canada Media Relations at 613-957-2983.

How to report problems with consumer products:

Complaints involving home HIV test kits or any other medical devices can be reported to the Health Products and Food Branch Inspectorate by calling the toll-free hotline at1-800-267-9675, or by writing to:

Health Products and Food Branch Inspectorate
Health Canada
Address Locator: 2003D
Ottawa, Ontario K1A 0K9

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Source: Health Canada


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