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Coronavirus company news summary – US FDA warns of potential false positives with Abbott Covid-19 test kits – Australia’s TGA approves Covid-19 rapid antigen self-tests

October 18, 2021

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The US Food and Drug Administration (FDA) has issued an alert regarding potential false-positive results with some Abbott Alinity Covid-19 test kits. The false-positive results are due to the software associated with the Alinity m SARS-CoV-2 AMP Kit and Alinity m Resp-4-Plex AMP Kit. Abbott has recalled the tests in order to correct the software issue, and the kits can continue to be used following the implementation of the software correction. The FDA advised caregivers to consider any positive result from tests using such kits to be presumptive and retest the patients using other authorised alternatives.

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