A staggering number of pregnancy test kits have been pulled from shelves across Australia after the Therapeutic Goods Administration (TGA) found them to be defective.
The watchdog tested all 36 products on the market, with nine manufacturers voluntarily withdrawing their products and a further five receiving a fail.
In addition, the TGA recalled two devices available on eBay for improper inclusion on the Australian Register of Therapeutic Goods. This means a total of 16 pregnancy tests have been withdrawn from sale.
The crackdown was prompted by reports of three instances where women had received false negative results using a One Step hCG urine pregnancy test from a family planning clinic.
The kits were found to be ineffective in determining whether urine contained the hCG hormone, which can sometimes be detected in extremely low levels after the first week of conception.
“Raised levels of hCG in the urine usually (but not always at it varies from woman to woman) occur about six days after fertilization,” the TGA explained.
In the review, the TGA assured customers that all remaining pregnancy tests available for sale are reliable and accurate.
“The five devices that failed have been subjected to a range of regulatory actions,” they said.
“All devices remaining on the market in Australia have been shown to work reliably and accurately.”
PregSure digital: Batch 16D119-1100
PregSure test strips: Batch 16D119-0000
First Response Digital Pregnancy Test and First Response Test & Reassure: Batches SU5341, SU6207, SU6237, SU6308, SU6335, SU6196, SU6305A, SU6315A
QuickVue One-Step hCG urine test has been suspended from sale, though failed batches were not supplied to Australia.
One Step Pregnancy test has also been removed, though failed batches were not supplied to Australia.
Details of the nine products voluntarily withdrawn from sale have not been released.