Four in ten pregnancy tests on the Australian market have been given a fail or been withdrawn from the market after the nation’s medicines watchdog put them to the test.
The Therapeutic Goods Administration took action after a family planning clinic reported three false negative results by the of the One Step HCG urine pregnancy test.
The TGA tested the device and found it to be insensitive and it was recalled.
The watchdog then went on to test all 38 devices on the market and nine manufacturers voluntarily withdrew their products.
The TGA tested the remaining 27 and found problems with a further five.
Releasing the results of that review the TGA said 22 of the 27 the test kits sampled passed testing and were shown to work reliably.
This means a total of 16 pregnancy tests have been withdrawn from sale.
“The five devices that failed have been subjected to a range of regulatory actions,” it said.
“All devices remaining on the market in Australia have been shown to work reliably and accurately,” it said.
One of the tests First Response Digital could not be tested because too many devices malfunctioned.
An investigation found a manufacturing flaw, which was corrected and the corrected devices were found to pass in subsequent testing.
The PregSure digital and Pregsure test strips were urgently recalled and cancelled from the list of therapeutic goods for sale in Australia.
Sale of the Quickvuew One stephCG urine test kit was suspended by the TGA then removed from sale in Australia by the company.
The One Step Pregnancy test was withdrawn by the company.
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