THE TGA has completed a review of all human chorionic gonadrotopin (hCG) pregnancy tests on the market, with some devices found not to work reliably and accurately, and consequently either corrected or removed from the market.
The review followed three false negative results of the One Step HCG urine pregnancy test from a family planning clinic, with the model shown to be insensitive, and cancelled from the ARTG.
All sponsors of hCG tests were contacted by the TGA and asked to supply information - at which point nine suppliers cancelled their ARTG entries, while the TGA also cancelled two devices for improper inclusion on the register.
Samples of the 27 remaining devices were tested, with 22 passing and a range of regulatory actions applied to the other five.
"All devices remaining on the market in Australia have been shown to work reliably and accurately,'" the TGA said.
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