At-home COVID-19 test recalled due to potential false positives

In this undated photo provided by Ellume the use of an at home self-administered rapid coronavirus test developed by Australian manufacturer Ellume is demonstrated. (Ellume via AP)

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In this undated photo provided by Ellume the use of an at home self-administered rapid coronavirus test developed by Australian manufacturer Ellume is demonstrated. (Ellume via AP)

An at-home COVID-19 test is being recalled for having a “higher-than-acceptable” false positive test result, according to the U.S. Food and Drug Administration.

More than 2.2 million Ellume COVID-19 Home Tests are included in the recall. The tests were manufactured between Feb. 24 to Aug. 11 and distributed from April 13 to Aug. 26.

The FDA has received 35 reports of false positive results and no deaths have been reported, according to the FDA. The recall is a Class 1 recall, which is the most serious type of recall.

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“In recent weeks, we noted an increased chance that Ellume COVID-19 Home Tests from specific product lots may provide an incorrect positive result,” read a statement from Dr. Sean Parsons, CEO and founder of Ellume. “Following a thorough investigation, we isolated the cause and confirmed that this incidence of false positives is limited to specific lots. In response, we worked with the Food and Drug Administration (FDA) to voluntarily remove affected Ellume tests from the market. Importantly, the reliability of negative results is unaffected by this issue.”

On Oct. 1, Ellume sent a letter to affected customers requesting the tests be removed from shelves and sales stopped, according to the FDA. Since then, the company identified additional affected lots.

Ellume is advising test users to check if their product is part of the affected lot. If it is, they should visit www.ellumecovidtest.com/return, call 1-888-807-1501 or email productsupport@ellume.com.

To check if a test is part of the affected lots, visit the Medical Device Recalls website to compare lot numbers. Lot numbers are posted on a sticker on the side of the Ellume tests.

Test users should also contact their health care provider, urgent care facility or other COVID-19 testing site to request a COVID-19 molecular diagnostic test to confirm a positive result.

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The antigen test uses a nasal sample to detect proteins from the SARS-CoV-2 virus, according to the FDA. The test is available without a prescription and can be used by people with or without COVID-19 symptoms. The home test reportedly uses an analyzer that connects with a smart phone app to show people how to use the test and understand the results.

The FDA issued an emergency use authorization for the Ellume COVID-19 Home Test on Dec. 15 and authorized a revision on Feb. 11 to allow emergency use of the test.

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