Pregnancy tests removed from market: TGA


happy woman with pregnancy test

Some pregnancy tests have been removed from the Australian market following a TGA review

The TGA has completed a review of all human chorionic gonadotropin (hCG) pregnancy self-test kits on the Australian market to ensure they meet sensitivity claims.

Some devices were found not to work reliably and accurately and have either been corrected or removed from the market.

All devices remaining on the market in Australia have been shown to work reliably and accurately, the TGA says.

These kits rely on detecting the hCG hormone and some have claimed to be able to detect extremely low levels, as would be found in the first week after conception.

Levels of hCG rise rapidly in subsequent weeks after conception and can be detected by less sensitive tests.

After a report of three false negative results (insufficient sensitivity) of the One Step HCG urine pregnancy test from a family planning clinic, the TGA tested the model and found it to be insensitive.

It was then recalled and cancelled from the Australian Register of Therapeutic Goods (ARTG).

In response to this, 36 point-of-care or self-test urine pregnancy test kits on the ARTG were identified and an additional two were identified on eBay. To be marketed in Australia, a urine pregnancy test kit must be included on the ARTG administered by the TGA.

The TGA contacted all sponsors to provide information on the devices. Rather than supply information, nine sponsors cancelled their ARTG entries and stopped supply. In addition, the TGA cancelled two devices for improper inclusion on the ARTG.

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. A total of 22 out of the 27 (81%) of the 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 summarised in the table below.

One product (First Response Digital from Church and Dwight) could not be tested as too many devices malfunctioned. All affected batches were recalled from pharmacies.

An investigation by the sponsor revealed a manufacturing flaw, which was corrected and the corrected devices were found to pass in subsequent testing.

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