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.
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