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Kit Recall

Test maker Ellume has recalled nearly 200,000 of its at-home COVID-19 test kits, the New York Times reports.

According to Reuters, tests from certain lots may give false positive results due to a manufacturing issue. 360Dx further reports that the US Food and Drug Administration released an alert warning of the issue and recommended that users who received a positive result from one of the affected lots seek confirmatory testing. Negative results, it adds, are not affected by the issue.

The Times says that the recalled kits represent about 5.6 percent of the 3.5 million test kits the Australia-based Ellume has sent to the US.

Ellume's chief executive, Sean Parsons, tells the Times that 427,000 test kits overall were affected by the issue, including ones provided to the US Department of Defense. "I'm very sorry that this has happened," he adds at the Times. "We're all about chasing accuracy, and to have these false positives is disappointing."

360Dx says the FDA is working with Ellume to assess its manufacturing checks and take steps to address the issue.