Regulator recalls millions of COVID-19 home test kits for accuracy defect

*The US Food and Drug Administration is recalling approximately two million Ellume at-home COVID-19 test kits over a tendency to return ‘false-positive’ results

Isola Moses | ConsumerConnect

In view of a tendency of the product return “false-positive” results, the United States (US) Food and Drug Administration (FDA), again, is recalling nearly two million Ellume at-home COVID-19 test kits.

ConsumerConnect learnt the country’s regulatory agency listed the recalled kits as “Class I,” meaning it is the most serious type.

The FDA was first informed about the potential defect last month, and since then, has identified additional lots that may be affected, agency report stated.

The kits are sold over-the-counter and can be administered at home, making them a faster way to test people instead of relying on tests that are administered in a healthcare setting.