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Advisory

2005-42
May 13, 2005
For immediate release

Health Canada advises consumers to not use New Choice pregnancy test

OTTAWA - Health Canada is advising consumers not to use New Choice pregnancy test because this product is not licensed for sale in Canada.

The product is used for the early detection of pregnancy by testing for the presence of the hormone human chorionic gonadotropin (hCG) in a urine sample.

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

Consumers who wish to verify that the pregnancy test kit that they plan to purchase is licensed can access the Next link will open in a new window Medical Devices Active Licence Listing.

Home-use pregnancy test kits are classified as Class 2 medical devices in the Medical Device Regulations of Canada's Food and Drugs Act. As such, they require a licence to be imported or sold in Canada.

Anyone having purchased New Choice Pregnancy Test is asked to not use the product. Consumers who have already used the product and are concerned about results are advised to seek medical assistance.

The importer has been informed to stop sale of the test kits and further compliance actions, such as an import alert to stop the device from crossing the border, may be taken by Health Canada.

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Health Canada
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Last Updated: 2005-05-13 Top