Health Canada is coming down hard on IND Diagnostic, suspending all of the company's licenses and halting all of its sales in the country.
IND makes test kits for women's health and infectious diseases for both over-the-counter and lab uses, and the regulator says it stepped in over concerns with the company's management systems and distribution practices.
Health Canada says it caught IND importing unlicensed medical devices into the country, and while it isn't aware of the company selling the unregulated tech in Canada, it is continuing to monitor the situation. The company has since voluntarily recalled the unlicensed devices.
The action wasn't driven by an identified issue with a specific diagnostic test, Health Canada said, but IND's practices cast doubt on the efficacy of all its products. The organization suggests patients who used IND's diagnostic kits seek repeat assays.
IND hasn't commented on the ban, and Canada's CTV News reports that an anonymous employee said the company is in talks with its legal counsel to resolve the issue.
Much of IND's business came in selling products to private label manufacturers, companies that would purchase IND's technology and rebrand it under other names, according to Health Canada.
- read Health Canada's announcement
- check out CTV's story