Archived – Health Canada is Warning Canadians Not to Use Clean Testing HIV Home Test Kit, or Any Home HIV Test Kit

Starting date:

June 22, 2009

Posting date:

June 22, 2009

Type of communication:

Advisory

Subcategory:

Medical Device

Source of recall:

Health Canada

Issue:

Unauthorized products

Audience:

General Public

Identification number:

RA-110003490

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  Media enquiries
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  Public enquiries

Health Canada is advising Canadians not to use Clean Testing HIV Home Test Kit, or any HIV home test kits, as these are unlicensed medical devices and may provide false test results.

The Clean Testing HIV Home Test Kit, available online at cleantesting.com, is promoted as a self-test kit to determine whether an individual has been infected with Human Immunodeficiency Virus (HIV). This kit is unlicensed and has not been evaluated by Health Canada for safety and effectiveness. Inaccurate test results may fail to indicate HIV in an infected individual, or indicate HIV when none is present.

Under the Medical Devices Regulations, home HIV test kits require a device licence issued by Health Canada before they can be advertised or sold. It is illegal to advertise or sell unlicensed medical devices of this class in Canada.

Currently, there are no HIV test kits that have been authorized for sale for home use in Canada.

Health Canada has requested that Clean Testing stop sale of the device and notify all customers not to use the kit. Health Canada will continue to monitor the situation and take appropriate action to mitigate the risk. Health Canada advises Canadians not to purchase these products from the Internet or from any other source.

Patients who are concerned about their HIV status should talk to their doctor. Patients that have used these test kits should also consult with their doctor to evaluate the need to conduct proper testing. Health Canada reminds Canadians that home test kits are not a replacement for professional health care, and that patients who have used a home HIV test kit should contact their physician for follow-up testing and counselling.

For more information on home test kits, see 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.

Complaints involving home HIV test kits can be reported to the Health Products and Food Branch Inspectorate by calling the toll-free hotline at 1-800-267-9675, or by writing to:

Health Products and Food Branch Inspectorate

Health Canada

Address Locator: 2003D

Ottawa, Ontario K1A 0K9

Consumers requiring more information about this advisory can contact Health Canada's public enquiries line at 613-957-2991, or toll free at

1-866-225-0709.

Media enquiries

Health Canada

613-957-2983

Public enquiries

613-957-2991

1-866-225-0709