Numerous home pregnancy tests recalled after false negative results reported

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Monday, March 27, 2017

A number of at-home pregnancy tests were recalled in Australia last week after customers and clinics concluded false negative results were received. A market-wide investigation made by the Therapeutic Goods Administration (TGA) concluded that five commercially available products displayed false negative results. A further nine products were taken off the shelf after the suppliers chose to withdraw local sales rather than provide information to the TGA.

The One Step hCG (human chorionic gonadotropin) urine pregnancy test came to the attention of the TGA after a family planning clinic reported three cases of false negative readings of the test. After further analysis, the TGA discovered the pregnancy tests were incapable of detecting the presence of the (hCG) hormone, an early indicator of pregnancy. Of the twenty-seven products analysed, twenty-two were deemed accurate and reliable. The TGA said in a media release on Wednesday that the five products that failed the test were "subjected to a range of regulatory actions".

Erin Turner, head of policy at the consumer advocacy group Choice said the results are "astounding". "Anyone who has bought a test that is affected by the recalls should approach the retailer for a refund and, importantly, see a doctor for further medical advice," said Turner. "Whatever result you're hoping for, it's essential that pregnancy tests are accurate and trustworthy."

While five products were named, the TGA have yet to announce the names of the other nine products taken off the shelves.

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