Heaps Of Aussie Pregnancy Test Kits Have Been RECALLED
Five of Australia’s 27 commercially available pregnancy tests have failed a review into results testing, and another nine were not tested before being withdrawn from sale.
A family planning clinic raised the alarm when it notified the Therapeutic Goods Administration of three ‘‘false negative results’’ of the One Step HCG Urine pregnancy test.
The TGA then examined the test and was found to have insufficient sensitivity to pick up the human chorionic gonadotropin (hCG) hormone that is an early indicator of pregnancy.
It wasn’t just the One Step HCG test that was recalled, however, as another 36 tests sold over-the-counter and two sold on eBay were also pulled.
The TGA contacted all suppliers, with nine cancelling their supplies.
“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.” The failed batches of the Genesis Biotech PregSure digital test were urgently recalled and the Minco Import and Export’s One Step Pregnancy Test was removed from the register.
The TGA is now considering action against Thermo Fisher Scientific Australia over the failed batches of its QuickVue One-Step hCG urine test kit.
The First Response Digital from Church and Dwight, could not be tested as too many devices malfunctioned.