More than a dozen home pregnancy tests have been pulled from the shelves after regulators found some tests were giving false results.
Five out of 27 pregnancy test kits available on shelves failed testing by authorities. Another nine manufacturers chose to stop local sales without being tested, resulting in a total of 14 brands being removed from stores.
A family planning clinic alerted the Therapeutic Goods Administration (TGA) after three pregnant women used the One Step HCG urine pregnancy test and were given a false negative result.
The kit was tested and found to be “insensitive” to detecting the human chorionic gonadotropin (hCG) hormone.
The One Step HCG urine pregnancy test has now been recalled and cancelled from the Australian Register of Therapeutic Goods.
“Samples of the remaining 27 devices were acquired and tested for whether they recognised only hCG (not other hormones), how sensitive they were to hCG and if the labelling was correct,” the TGA said in a statement.
“A total of 22 of 27 (81 per cent) test kits sampled passed testing and were shown to work reliably. The five devices that failed have been subjected to a range of regulatory actions.”
One test, the First Response Digital from Church and Dwight, could not be tested because too many devices malfunctioned, according to the TGA.
All the affected batches were recalled from pharmacies and the "manufacturing flaw" was corrected with other devices passing more testing.
"All devices remaining on the market in Australia have been shown to work reliably and accurately," the TGA said.
Consumers are being urged to return recalled kits to a pharmacy for an exchange or a refund.
Have you been affected? Our reporter Rachel Curtis would love to speak to you: [email protected]