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.
“The suspension means the devices can no longer be legally sold in Canada by any person,” the department said in a news release.
“Health Canada’s decision to suspend these licences is not based on an identified issue with the safety and effectiveness of any particular device.”
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 the news release it is not aware the unlicensed products were ever sold in Canada. The department urged anyone with complaints to call 1-800-267-9675.
“Should patients or health professionals wish to confirm previous test results, there are authorized alternatives available in Canada for all the test kits whose licences have been suspended,” the department said.
IND has voluntarily recalled the products.
A person answering the phone at the company, who refused to be identified except as an employee, said the company is seeking legal advice.
“We’re speaking with our legal counsel on this matter,” the employee said, declining further comment.