"In recent weeks, we noted an increased chance that Ellume COVID-19 Home Tests from specific lots may provide an incorrect positive result. Following a thorough investigation, we isolated the cause and confirmed that this incidence of false positives is limited to specific lots. We worked with the Food and Drug Administration (FDA) to voluntarily remove affected Ellume tests from the market," the company said in a statement on its website.
Around 190,000 test kits delivered from April to August have now been withdrawn, but less than 1% of those provided false results, the ABC broadcaster reported.
Last year, the company's test kits were approved by the FDA for emergency use. Ellume signed a contract with the US on the supply of the home tests amounting to $300 million.