A number of home pregnancy kits have been removed from sale in Australia following a review undertaken by the Therapeutic Goods Administration (TGA), which found the affected tests did not work reliably or accurately.
The TGA reviewed all human chorionic gonadotropin (hCG) kits on the Australian market after three women from a family planning clinic received false negative responses (i.e testing negative when they were, in fact pregnant), after using the One Step HCG urine pregnancy test. The model was subsequently tested, "shown to be insensitive", and was recalled and cancelled from the Australian Register of Therapeutic Goods (ARTG). To be marketed in Australia a urine pregnancy test kit must be included on the ARTG.
The TGA then identified 36 urine pregnancy tests kits on the ARTG, along with a further two being sold on eBay.
When the TGA contacted test manufacturers for information regarding their products, nine manufacturers chose to pull their kits from supply, rather than provide the requested details. Two kits were cancelled for "improper inclusion" on the ARTG.
The 27 remaining kits were then tested on three different aspects:
- whether they recognised only hCG (not other hormones)
- how sensitive they were to hCG
- if the labelling was correct.
Results indicated that 22 out of the 27 (81 per cent) of the kits passed TGA testing and were shown to work reliably. Five kits failed.
One product, First Response Digital, which is manufactured by Church and Dwight, was initially unable to be tested as too many of the devices malfunctioned. Consequently, all tests were recalled from pharmacies and subjected to further testing by the manufacturer. According to the TGA, an investigation revealed a "manufacturing flaw". The defect was since corrected and passed later tests conducted by the TGA.
The following products have been recalled from pharmacies:
- Genesis Biotech: PregSure digital, Pregsure test strips, batches 16D119-1100, 16D119-0000
- Church and Dwight Australia: First Response Digital Pregnancy Test (also included in First Response Test & Reassure), batches: SU5341, SU6207, SU6237, SU6308, SU6335, SU6196, SU6305A, SU6315A
The TGA indicated that they are considering undertaking further regulatory action against Thermo Fisher Scientific Australia, who manufacture the QuickVue One-Step hCG urine test kit. Failed batches of this product were not supplied in Australia but are sold through third party internet sites.
A summary of the TGA's finding are presented below:
According to CHOICE, consumers are urged to return affected kits to pharmacies for exchange or refund.
CHOICE is also seeking further information about the brands of pregnancy kits removed from sale in Australia as the TGA has not disclosed their names.