TGA issues warning over unapproved RATs



Australia’s medical regulator has issued a fresh warning not to buy rapid antigen tests that have not been approved for use in the country.

It comes following concerns some types of RATs are being repackaged or relabelled for sale without all the components inside.

The Therapeutic Goods Administration has also warned some retail outlets or online stores may try to sell kits unsuitable for use at home.

The administration has already approved 32 different types of rapid antigen tests for use in Australia.

“(Unapproved RATs) have not been assessed by the TGA, meaning they do not come with the same assurances of safety, effectiveness and quality as those that have met Australian regulatory requirements,” the TGA said in a statement.

“Unapproved versions may not work as expected, or work at all.”

While supply issues for rapid antigen tests, largely seen during the peak of the Omicron wave, have subsided, the administration said it was important people check whether a test had been approved in Australia before being used.

The TGA spokesman said users should purchase the tests from Australian retailers if possible and check if the test was included on the Australian register of therapeutic goods.

“Avoid purchasing RATS from overseas websites — your order may be stopped at the Australian border if you import a quantity greater than what would be reasonable for personal use,” the spokesman said.

The administration has warned of significant fines for people importing unapproved tests.

It comes as a further 28 deaths have been recorded from COVID-19 in the past reporting period — 26 in Victoria and two in NSW.

NSW registered another 9466 cases on Friday, while there were 6545 in Victoria.


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