After being contacted by the regulator to provide information on the devices, nine suppliers withdrew their products from sale rather than undergo testing. Another two were removed from the ARTG by the TGA for being improperly included. Other five were found to be ineffective. The TGA even is considering “further regulatory action” against one supplier, Thermo Fisher Scientific Australia, which produces the QuickVue One-Step hCG urine test kit. The kits that were found faulty were found to be ineffective in detecting the hCG hormone. Only names of the kits that failed testing have been made public. The products that were voluntary recalled remain unknown.
The recalled prodicts are: 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 ceased supply and QuickVue One-Step hCG urine test is having further regulatory action.