Recalls and alerts more than 4 years old are automatically archived. While this information can still be accessed in the database, it has not been altered or updated since it was archived. Web pages that are archived on the Web are not subject to the Government of Canada Web Standards. As per the Communications Policy of the Government of Canada, you can request alternate formats by contacting us.
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
- Medical Device
- Source of recall:
- Health Canada
- Important Safety Information, Unauthorized products
- General Public
- Identification number:
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.
|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|
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
Address Locator: 2003D
Ottawa, Ontario K1A 0K9
For more information
Stay connected with Health Canada and receive the latest advisories and product recalls using social media tools.