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Health Canada continues to identify unlicensed home test kits being sold to Canadians

Starting date:
January 30, 2015
Posting date:
January 30, 2015
Type of communication:
Information Update
Subcategory:
Medical Device
Source of recall:
Health Canada
Issue:
Important Safety Information, Unauthorized products
Audience:
General Public
Identification number:
RA-43573

Issue

Health Canada is reminding Canadians about the risks of purchasing unlicensed home-use diagnostic test kits following recent compliance and enforcement actions undertaken by the Department.

Home-use diagnostic test kits must be licensed by Health Canada before they can be imported or sold in Canada. The authorization from Health Canada means that the kit has been evaluated for safety and effectiveness. To confirm whether a device is licensed in Canada, consumers can refer to the Medical Devices Active Licence Listing (MDALL).

It is important to note that there are currently no HIV or sexually transmitted disease (STD) diagnostic test kits authorized by Health Canada for home use. Health Canada reminds Canadians who are concerned about their health to speak with their healthcare practitioner.

In addition, consumers who purchase test kits over the Internet and/or by mail order may be at risk of purchasing unlicensed or defective product.

Canadians can monitor the chart below for updates to the list of unlicensed test kits found on the Canadian market by the Department.

List of unlicensed test kits
Test Kit Indication Retail Location Company Date Added
iCare gonorrhea www.stdtestcanada.com Future Ventures January 30, 2015
iCare syphilis www.stdtestcanada.com Future Ventures January 30, 2015
iCare chlamydia www.stdtestcanada.com Future Ventures January 30, 2015
iCare hepatitis B www.stdtestcanada.com Future Ventures January 30, 2015

Health Canada's It's Your Health series has articles on Medical Test Kits for Home Use and Buying Medical Devices over the Internet.

Canadians are also encouraged to report complaints about medical devices to the Health Products and Food Branch Inspectorate by calling toll-free to 1-800-267-9675, or by writing to:

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

Media enquiries

Health Canada
613-957-2983

Public enquiries

613-957-2991
1-866-225-0709

For more information

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