In a “higher than expected” number of cases, women thought they were pregnant after using the product, only to be disappointed — or relieved — by more convincing evidence later, the company said in a letter released by Health Canada Tuesday.
“These women … either had their menstrual period or saw their doctor, who determined that the woman was not pregnant,” said the alert from Durex.
The company said it had suspended all sales of the Confirm Clearly Smart Pregnancy Test and Confirm Clearly Refills and is removing them from stores. Consumers with unused products can return them for a refund, the firm said.
Defects in the test kits may be causing the false positives, although rare medical conditions and certain drugs can have the same effect, the statement said.
“It is therefore very important that any woman suspecting a pregnancy consult with her doctor to confirm the pregnancy and initiate the appropriate prenatal care, if necessary, as soon as possible,” the alert said. “It is not expected that these defects are likely to cause serious adverse health consequences.”
The recall was taken voluntarily and Durex informed Health Canada about its actions, said Jason Bouzanis, a spokesman for the regulator. Health Canada asked the manufacturer to publicly announce the move “to ensure that all Canadians would have access to information about the recall.”
But the letter was posted only on the government department’s Web site and no news release or other statement was released directly by Durex.
A company spokesman was not available for comment yesterday, although a toll-free number was available for consumers to discuss the recall.
Could you imagine the stress these tests have caused many families. The exictement of thinking your were finally pregnant…or the fright wondering what you are going to do if a new baby wasn’t in your plans.