Several pregnancy tests recalled after review found they were ineffective

If you’ve received an inaccurate pregnancy test reading in the past, this may be why…

Several pregnancy tests in Australia have been recalled after testing by the Therapeutic Goods Administration found they were ineffective.

“The TGA has completed a review of all human chorionic gonadotropin (hCG) pregnancy self-test kits on the Australian market to ensure they meet sensitivity claims,” TGA said in a statement.


“Some devices were found not to work reliably and accurately and have either been corrected or removed from the market.”

The review was sparked after a family planning clinic reported three false negative results by the One Step HCG urine pregnancy tests.

“After a report of three false negative results (insufficient sensitivity) of the One Step HCG urine pregnancy test from a family planning clinic, this model was tested by the TGA, shown to be insensitive, recalled and cancelled from the Australian Register of Therapeutic Goods (ARTG),” TGA said in a statement.

The watchdog then tested all 38 pregnancy self-test kits on the Australian market, with nine companies immediately stopping supply of their kits and another five found to be defective.

The TGA also cancelled two devices for improper inclusion on the ARTG.

In total, 16 pregnancy tests were withdrawn from sale.

The regulator stressed that all tests remaining on the market are effective.

“All devices remaining on the market in Australia have been shown to work reliably and accurately,” the TGA confirmed.

Further information on the pregnancy test investigation can be found here.