Home pregnancy tests get recalled in Australia
Even as sales of do-it-yourself-kits continue to soar in recent years, there are companies offering them still unable to improve their offerings. Lately, several home pregnancy kits in the market were recalled for wrongly informing pregnant women of negative results after using the products.
D-I-Y pregnancy kits need to be sensitive enough to recognise the human chorionic gonadotropin (hCG) hormone that indicates pregnancy. Unfortunately, there are products that do not meet the mark.
It is a problem not unique to Australia alone. Over a decade ago, thousands of women in the UK also got inaccurate or false negative results after using home pregnancy testing kits.
Such a circumstance involving a home pregnancy kit brand from San Antonio, Texas alarmed not just the women who got the false readings but also medical professionals. Doctors surmised that the pregnant women misled would continue to drink, smoke, take over-the-counter drugs or go through medical procedures that could harm their babies, the Telegraph reported.
The case with Australia
In the case the products that had to be recalled in Australia, a total of 14 brands have ceased sale, while three more will be recalled following a review conducted by the Therapeutic Goods Administration (TGA), News Corp Australia reported.
The crackdown came when a notification report of three false negative results from the use of the One Step HCG urine pregnancy test was made by a family planning clinic. The TGA proceeded to test the product, which was found to be “insensitive.” The product was recalled and cancelled from the Australian Register Therapeutic Goods. Succeeding tests were done on the remaining pregnancy test kits on the register.
The industry regulator got in touch with all of the manufacturers on the register asking for information on their pregnancy kits. Of those reached, nine suppliers withdrew their products from sale instead of undergoing testing.
There are devices in the market that still work, the regulator said. Nonetheless, consumer advocacy organisation Choice lamented that only the details of five of the kits that have been failed testing and were recalled have been disclosed. In the meantime, the consumers who purchased the faulty home pregnancy kits were advised to return the items to a pharmacy for refund or replacement.
The products recalled include 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
One Step Pregnancy test has been removed from the ARTG and supply has stopped. Failed batches were not supplied to the Australian market. On the other hand, QuickVue One-Step hCG urine test is undergoing further regulatory action considered against its sponsor, even if failed batches were not supplied to Australia.
