CuraHerbDistributor.com Selling Unlicensed Home-Use HIV and STDs Test Kits

Starting date:

September 10, 2012

Posting date:

September 10, 2012

Type of communication:

Advisory

Subcategory:

Miscellaneous

Source of recall:

Health Canada

Issue:

Important Safety Information

Audience:

General Public

Identification number:

RA-15051

• 
  Issue
• 
  What you should do
• 
  Affected products
• 
  Report health or safety concerns
• 
  Media enquiries
• 
  Public enquiries
• 
  What Health Canada is doing
• 
  Images

CuraHerbDistributor (curaherbdistributor.com) is attempting to sell online unlicensed home-use HIV test kits for use with urine, saliva and blood samples. It is important to note that there are currently no HIV test kits authorized for home use in Canada.

Issue

CuraHerbDistributor's kits carry the "Home Aware" brand and have not been evaluated by Health Canada for safety and effectiveness. Accordingly, these 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.

In addition, CuraHerbDistributor is also attempting to sell online a number of other test kits under the "Home Aware" brand. Health Canada has not licenced "Home Aware" tests kits for any of the following conditions indicated on the website, namely syphilis, trichomonas vaginalis, gonorrhea, chlamydia, hepatitis (B/C) or herpes simplex.

What you should do

• Consult your healthcare practitioner if you have used any home-use test kits sold via the curaherbdistributor.com website or under the "Home Aware" brand and are concerned about your health.
• Report any complaints related to test kits sold via the curaherbdistributor.com website or under the "Home Aware" brand to Health Canada (see below).

Affected products

Report health or safety concerns

Complaints involving test kits sold via the curaherbdistributor.com website or under the "Home Aware" brand or any other 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

Media enquiries

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

Public enquiries

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 at 1-866-225-0709.

What Health Canada is doing

Health Canada is reminding Canadian retailers that it is illegal to advertise or sell unlicensed HIV and STD test kits in Canada. In addition, Health Canada has alerted its international partners about Curaherbdistributor.com test kits available via the Internet.

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

Health Canada is working with the Canadian Border Services Agency to prevent importation of all CuraHerbDistributor.com test kits and will continue to monitor the situation, take appropriate action and inform Canadians, when necessary

Images

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