DELTA, B.C. – Health Canada has pulled the licenses for all medical devices sold by a Delta, B.C., company, including home test kits to detect pregnancy and ovulation.
IND Diagnostic sold the kits directly or through 13 private label manufacturers, but Health Canada became concerned after learning the company was importing unlicensed products for export to other countries.
Among the company’s products are kits for screening for urinary tract infections, infectious diseases and illicit drugs and some were sold for home use in retail outlets, including dollar stores, while others were sold only for use by health professionals.
Health Canada says in a news release the decision to suspend the medical device licenses for the products means they cannot be sold legally in Canada, though the department says it is not aware they ever were.
The department also says the decision to suspend IND’s licenses is not based on any identified issue with the safety or effectiveness of the products, though it urges anyone with complaints about the products to call 1-800-267-9675.
A person answering the phone at the company, who refused to be identified except as an employee, said the company is seeking legal advice and he declined further comment.
Friday, February 8, 2013