OTTAWA, Feb. 8, 2013 /CNW/ - Health Canada today suspended all medical device licences issued to and associated with IND Diagnostic of Delta, B.C., under its powers in the Food and Drugs Act, because of concerns about the company's management systems and distribution practices. The suspension means the devices can no longer be legally sold in Canada by any person. Health Canada's decision to suspend these licences is not based on an identified issue with the safety and effectiveness of any particular device.
The devices whose licences were suspended were sold directly by IND Diagnostic or by one of 13 private label manufacturers. The private label manufacturers are companies that purchased IND Diagnostic products and sold them under other names.
The devices include test kits used in pregnancy and ovulation, screening for blood in stool, urinary tract infections, infectious disease and illicit drugs. Some of the tests were sold in retail outlets, including discount/dollar stores for home use, while others were only sold for use by health professionals or laboratories.
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.
In addition to the concerns about IND Diagnostic's management system for licenced devices, Health Canada found the company was importing unlicensed medical devices mainly for export to other countries. Health Canada is not aware of these unlicensed devices being distributed to the Canadian public or the health care system. When Health Canada discovered this situation, it notified its international health partners and the Canada Border Services Agency to help ensure the devices were no longer being imported. IND Diagnostic has voluntarily recalled these unlicensed devices.
Health Canada is continuing to monitor this situation. If the Department is made aware of ongoing sales of products whose licences have been suspended, it will consider taking further action as warranted. Complaints about medical devices can be reported to the Health Products and Food Branch Inspectorate by calling the toll-free hotline at 1-800-267-9675, or by writing to:
Health Products and Food Branch Inspectorate
Health Canada
Address Locator: 2003D
Ottawa, Ontario K1A 0K9
SOURCE Health Canada
Source: www.prnewswire.com
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