FDA recalls 2 million Ellume home COVID-19 test kits due to false positives: NPR – Community News
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FDA recalls 2 million Ellume home COVID-19 test kits due to false positives: NPR

FILE – This Thursday, August 2, 2018, a file photo shows the U.S. Food and Drug Administration building behind FDA logos at a bus stop on the agency’s campus in Silver Spring, Maryland.

Jacquelyn Martin/AP


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Jacquelyn Martin/AP


FILE – This Thursday, August 2, 2018, a file photo shows the U.S. Food and Drug Administration building behind FDA logos at a bus stop on the agency’s campus in Silver Spring, Maryland.

Jacquelyn Martin/AP

The US Food and Drug Administration has announced a recall of approximately 2 million COVID-19 home test kits made by Australian biotech company Ellume.

The federal regulatory agency says the test kits could produce “false positives” due to a manufacturing defect. The company first notified the FDA of the defect in some lots in October.

On Wednesday, the FDA said it had identified additional batches affected by the manufacturing defect. The defective tests were manufactured by Ellume between February 24, 2021 and August 11, 2021. So far, 35 false positives from these tests have been reported to the FDA.

The FDA described the recall of the Ellume tests as “the most serious type,” known as a Class I recall.

Earlier this year, the Biden administration signed a $231.8 million deal with Ellume to increase the availability of the tests in the US market. Ellume’s contract with the Department of Defense and the Department of Health and Human Services helped fund the company’s first plant in the country, which opened in Frederick, Maryland, in May.

The over-the-counter nasal swabs can be purchased at a pharmacy or supermarket and taken at home. Home kits – like Ellume’s – detect small parts of the virus that causes COVID-19 and are thought to provide fairly reliable results in about 15 minutes, especially in people who are symptomatic.

The FDA and Ellume say the reliability of negative results has not been affected by the problem found in the faulty tests. In a statement posted to the company’s website, founder and CEO Dr. Sean Parsons joined those who had received a false positive.

“[W]We understand that trust is central to fulfilling our purpose as a company, and we recognize that this incident may have shaken the confidence of some of those who trusted Ellume to help them manage their health and regain some control over their lives during this pandemic,” said Parsons.

Ellume says it has fixed the manufacturing problem, and federal regulators say they are monitoring the company’s efforts.

“The FDA continues to work with Ellume to review the company’s corrective actions, such as additional manufacturing controls and other corrective steps, to address the reason for the manufacturing problem and to ensure it is resolved and will not reoccur,” says the FDA. regulatory agency said in a statement.

Over-the-counter at-home test kits have become popular as the pandemic continues and as federal regulators have granted emergency approval to tests from a slew of companies.

In March, the FDA announced plans to streamline the authorization process for home tests. The agency updated that process in October.

Also last month, the White House announced an additional $1 billion allocation for home testing to reduce an ongoing national deficit.

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