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FDA Recalls Millions of Ellume Digital Diagnostics At-Home COVID-19 Tests Due to False Positives

This picture taken on December 21, 2020 shows COVID-19 coronavirus home test units that have been granted an Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA), at the production facility of Australian digital diagnostics company Ellume in Brisbane. - Ellume's product delivers results in just 15 minutes and will soon be available over the counter in pharmacies across the country worst-hit by the pandemic. (Photo by PATRICK HAMILTON/AFP /AFP via Getty Images)

The US Food and Drug Administration has issued a recall for around 2 million COVID-19 at-home test kits manufactured by Ellume, an Australian biotech business. Due to a manufacturing flaw, the test kits may yield “false positives,” according to the federal regulatory body. In October, the business notified the FDA of a defect in specific samples.

The FDA said on Wednesday that it has discovered further lots afflicted by the manufacturing problem. Ellume produced the faulty tests between February 24, 2021, and August 11, 2021. The FDA has received 35 false positives from these testing thus far. According to the FDA, the Ellume tests were recalled as “the most severe class,” known as a Class I recall. There is a risk of severe health consequences or death under this recall.

In this picture taken on December 21, 2020, an employee checks COVID-19 coronavirus home test units that have been granted an Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA), at the production facility of Australian digital diagnostics company Ellume in Brisbane. – Ellume’s product delivers results in just 15 minutes and will soon be available over the counter in pharmacies across the country worst-hit by the pandemic. (Photo by PATRICK HAMILTON/AFP /AFP via Getty Images)

FDA Recalls Ellume’s At-Home COVID-19 Tests Due to High False-Positive Results

According to a report from People (via Yahoo! News), this event followed a 200,000-kit recall earlier this month for the same issue due to “unacceptably high false-positive test results” of Ellume’s at-home COVID-19 tests. 

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FDA said the Ellume COVID-19 Home Test resulted in 35 false positives. Although they recorded no deaths. On the other hand, the agency added that false positives might lead to negative outcomes. These include unwarranted COVID-19 treatment from a healthcare provider or a delay in diagnosing a person’s genuine disease.

According to the health agency, the issue has no influence on the validity of negative test results. People who have bought an Ellume home COVID-19 test kit should check if they have one of the impacted test kits. They should input the lot number on this Ellume website. CBS News said the label with the lot number is attached to the side of the product box.

Ellume Reacts To FDA Recall

According to a company spokesperson, Ellume already fixed the manufacturing issue. Ellume has investigated the issue, identified the root cause, implemented additional procedures, and produced and shipped new items to the United States.

He further said that the Ellume team apologizes profusely for any anxiety or trouble caused by a false-positive result. According to FOX News, they have worked extensively to ensure test accuracy in all scenarios and will continue to do so.

The recall comes amid when COVID-19 tests for at-home use are scarce. Many pharmacies are out of stock. Even if they are, the tests cost about $24 each pair, which is a big commitment for many clients who need frequent testing.

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