Information Update - Multiple distributors selling unlicensed Home-Use HIV Test Kits via amazon.ca
 

Starting date:
November 28, 2014
Posting date:
November 28, 2014
Type of communication:
Information Update
Subcategory:
Medical Device
Source of recall:
Health Canada
Issue:
Unauthorized products
Audience:
General Public
Identification number:
RA-42749

November 28, 2014
For immediate release

OTTAWA – Health Canada is informing Canadians that multiple distributors (Positive Health, dailySupply, BestDealCA, eshopic, Urban Inspirations, grabthesale, and dealkings) are selling the unlicensed “OraQuick in Home HIV Test” kit via amazon.ca.

The “OraQuick in Home HIV Test” has not been authorized for sale in Canada, which means that Health Canada has not evaluated the kit for safety and effectiveness. There are currently no HIV test kits authorized by Health Canada for home use.

Canadians who have used any home-use HIV test kits and/or are concerned about their HIV status should talk to their healthcare practitioner.

Health Canada's It's Your Health series has articles on Medical Test Kits for Home Use and Buying Medical Devices over the Internet. To confirm whether a device is licensed in Canada, please refer to the Medical Devices Active Licence Listing (MDALL).

Health Canada has initiated compliance and enforcement actions and will continue to monitor the situation, take appropriate action and inform Canadians, when necessary.

Complaints about medical devices 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

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Health Canada
(613) 957-2983

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1-866 225-0709