A commercially available, home-use pregnancy test has been recalled in Australia after producing false negative results, prompting a sweep of the market that led to a further nine products being removed and more subjected to regulatory action.

The One Step HCG urine pregnancy test was recalled after a family planning clinic alerted the Therapeutic Goods Administration to three instances of false negative results.

The TGA found the test to be insufficiently sensitive to human Chorionic Gonadotropin (hCG), which is an early indicator of pregnancy. Some home-use tests claim to be able to detect extremely low levels of the hormone, as would be present within a week of conception.

The One Step test, sponsored by Minco Import and Export, was removed from the register of therapeutic goods allowed to be sold in Australia.

The result prompted the TGA to carry out a sweep of the market, the results of which were published on Wednesday.

Of the 36 point-of-care or self-test urine pregnancy test kits listed on the register , nine were not tested because their suppliers chose to cancel local sales rather than supply information to the TGA. Twenty-seven devices were tested for sensitivity to hCG and the accuracy of their labelling – 22 passed and were found to work reliably. The five that failed were “subjected to a range of regulatory actions”, the TGA said in a media release.

Failed batches of Genesis Biotech’s PregSure digital test and its PregSure test strips were subjected to an urgent recall.

The TGA was considering further regulatory action against Thermo Fisher Scientific Australia for failed batches of its QuickVue One-Step hCG urine test kit.

Another product, the First Response digital test from Church and Dwight Australia, could not be tested as too many devices malfunctioned. Affected batches were recalled, a manufacturing flaw was detected and corrected, and those devices passed subsequent tests.

Erin Turner, head of policy at the consumer advocacy group Choice, said five products subjected to regulatory action and nine removed from the register reflected a “massive failure” across the pregnancy testing market.

“It’s astounding that 14 products have been taken off shelves.

“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.

“Whatever result you’re hoping for, it’s essential that pregnancy tests are accurate and trustworthy.”

Turner noted that only five of the 14 affected products had been named and that Choice had asked the TGA to identify them all, “to help women who may have unknowingly paid for a dodgy product”.

Pregnancy causes a woman’s levels of hCG to rise rapidly, doubling every two to three days. The TGA advises that most kits detect hCG at 25 mIU/mL, or roughly about the time of a missed period.

The TGA did not respond to a request for the names of the kits removed from the market.