Health Canada Bans Company’s Test Kits

IND Diagnostics Inc. is in some serious trouble with the Canadian government. The Delta, British Columbia-based test kit manufacturer is banned from selling its products in the country as Health Canada investigates concerns with the company’s management systems and distribution practices.

Health Canada claims IND imported unlicensed medical devices into the country, though it did not distribute them within the Great White North. And while IND voluntarily has recalled the potentially problematic products, the government nevertheless pulled the licenses for all the company’s products as a precaution. The devices in question include pregnancy and ovulation test kits as well as screenings for fecal blood, urinary tract infections, illicit drugs and infectious diseases. IND sold the kits directly, by healthcare professionals or through 13 private label manufacturers.

Health Canada urged patients who used IND’s products to be re-tested. “Should patients or health professionals wish to confirm previous test results, there are authorized alternatives available in Canada for all the test kits whose licenses have been suspended,” the department said in a news release. Those with complaints should call 800-267-9675.

IND has not publicly responded to Health Canada’s charges, but an employee told CTV News the company is seeking legal advice. “We’re speaking with our legal counsel on this matter,” the unidentified employee told the broadcast giant, declining further comment.

ND makes test kits for women’s health and infectious diseases for both over-the-counter and lab uses. A full list of IND devices sold in Canada is available at:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/23151a-eng.php.