UPDATE – Thursday 28 July, 7:31am: The makers of the BD Veritor™ Plus System have told FIVEAA their product was not removed from the market by the TGA, but instead “the company made a commercial decision to voluntarily withdraw the test after determining it did not want to incur the costs associated with additional clinical data being required to provide additional evidence that it worked as intended on variants of SARS-CoV-2”.
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Australia’s medical regulator has removed a number of COVID RATs from the market since January.
A Health Departments spokesperson has told dailytelegraph.com.au:
“Two entries in the ARTG (Australian Register of Therapeutic Goods), sponsored by different companies, have been suspended from the ARTG, one of which is now cancelled and the other remains suspended.
“The suspended entry is still under investigation by the TGA.
“Another sponsor has received an infringement notice for failing to provide information and failing to provide adequate customer support.
“Since January 2022, four Rapid Antigen Tests (RATs) have been removed from the ARTG.”
According to the paper the watchdog is cracking down on manufacturers who have “failed to provide updated medical research on how the tests stack up against emerging COVID strains”.
The removed tests include CovClear by Medi-Stats, NowCheck by Life Bioscience and Covifind by Safe Interact.
FIVEAA BREAKFAST LIVE STREAM – TUES 26 JULY – WATCH HERE:
