HEALTH CANADA ISSUES ADVISORY WITH RESPECT TO NEW CHOICE PREGNANCY TEST

Health Canada has advised consumers not to use New Choice Pregnancy Test which is not licensed for sale in Canada. The product uses a urine test for the presence of the hormone chorionic gonadotropin (hCG). The product, which is manufactured by IND Diagnostic Inc. and distributed by Sales Enterprises Inc., has been available for purchase in Ontario, Quebec, and the Maritime Provinces.

Under Canadian law, pregnancy tests are classified as Class 2 medical devices and, thus, require a license in order to be imported into the country. Those having purchased the product are advised not to use it. If the test has been used, the consumer is advised to consult with a medical professional if they are concerned with the accuracy of the result. The importer has been ordered to halt the sale of the product. Other compliance actions may be taken by Health Canada to stop the importation of the test.

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