Health Canada has suspended all medical device licences issued to and associated with IND Diagnostic of Delta, B.C. The devices include test kits used in pregnancy and ovulation, screening for blood in stool, urinary tract infections, infectious disease and illicit drugs. Some of the tests were sold in retail outlets, including discount/dollar stores for home use, while others were only sold for use by health professionals or laboratories.

A letter from Health Canada with more details and the list of suspended products is attached. Additional information is also provided.

The purpose of this communication is to inform you that Health Canada has suspended all medical device licences issued to, and associated with, IND Diagnostic of Delta, British Columbia because of concerns about IND Diagnostic's quality management system and distribution practices. This suspension means the devices can no longer be legally sold in Canada by any person.

Please find attached a copy of a Health Canada Information Update and list of the affected medical devices.

The devices whose licences were suspended were sold directly by IND Diagnostic or by one of 13 private label manufacturers. The devices include test kits used in pregnancy and ovulation, screening for blood in stool, urinary tract infections, infectious disease and illicit drugs. Some of the tests were sold in retail outlets, including discount/dollar stores for home use, while others were sold for use by health professionals or laboratories.

Health Canada has no evidence to show that there have been failures in the safety or effectiveness of the devices. However, should patients or health professionals wish to confirm previous test results, there are licensed alternatives available in Canada for all the test kits whose licenses have been suspended.

Anyone with an existing inventory of the devices whose licences have been suspended should stop distribution.