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Canada Warns Not To Use Unapproved Pregnancy Test

Snowbaby

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Scotland
Consumers were advised Friday not to use a pregnancy test marketed under the name New Choice Pregnancy Test. The product is not licensed for sale in this country, Health Canada said.

The product, manufactured by IND Diagnostic Inc. of Delta, British Columbia and distributed by SCI International Inc. of Rockland, Maryland, has been available in Dollarama stores in Ontario, Quebec and the Maritimes.

Under the medical device regulations of Canada's Food and Drugs Act, home-use pregnancy test kits are classified as Class 2 medical devices in this country. As such, they require a licence to be imported or sold in Canada.

The importer has been ordered to stop sales of the test kits. Further compliance actions, such as an import alert to stop the device from crossing the border, may be taken, Health Canada said.

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