February 11, 2013 - IND Diagnostic, a medical device manufacturer based in Canada, is under scrutiny by Health Canada, the government watchdog agency. As of now, all sales of the company’s devices have been suspended in the country. Health Canada has also suspended all of IND Diagnostics' licenses.
IND Diagnostics manufactures testing kits for female health and wellness. The company also offers infectious disease testing kits for labs and over-the-counter use. According to Health Canada, the company’s distribution and management systems place it in non-compliance.
Health Canada caught IND Diagnostics importing medical devices into Canada without the proper licensing arrangements. While Health Canada has not caught the company selling these unlicensed devices, it is currently assessing the severity of the situation. As a show of good faith, IND Diagnostics has voluntarily recalled the non-licensed devices.
According to Health Canada, the suspension is not based on issues with a certain diagnostic test by the company; instead, the suspension follows unscrupulous distribution and management practices at the company. Health Canada has recommended that who underwent diagnostic tests with IND’s products repeat those assays with products from a different company.
The majority of IND Diagnostics' customers are private label manufacturers. Private label manufacturers purchase proudcts then rebrand them with a different name.
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