Key TakeawaysEllume has recalled over 2 million of its at-home COVID-19 test kits since October.A manufacturing error resulted in higher-than-expected false-positive test results.The FDA classified the recall as Class I, the most serious type of recall, and warned customers about serious adverse effects.

Key Takeaways

Ellume has recalled over 2 million of its at-home COVID-19 test kits since October.A manufacturing error resulted in higher-than-expected false-positive test results.The FDA classified the recall as Class I, the most serious type of recall, and warned customers about serious adverse effects.

Ellume recalled around 195,000 of its at-home COVID-19 tests in October because of a manufacturing error that resulted in too many false-positive results.The Australian company has since identified more than 2 million affected tests in the United States.

The Food and Drug Administration (FDA) today classifiedthe recall ofEllume’s COVID-19 Home Testas Class I, the most serious type of recall. The agency warned that the “use of these tests may cause serious adverse health consequences or death.”

“There are ancillary risks from receiving a potentially false positive result that could cause harm, such as delaying diagnosis or treatment for the actual cause of a person’s illness that is not COVID-19,” an Ellume spokesperson wrote in an email to Verywell. “We share this concern, which is why we worked quickly to remove affected tests from store shelves and online platforms and notified impacted customers and retailers.”

The spokesperson added that the FDA did not indicate that the tests themselves caused harm, but rather the impact of the manufacturing error.

“The Ellume team offers its sincere apologies for the stress or difficulties people may have experienced due to a false-positive result. We have and will continue to work diligently to ensure test accuracy, in all cases," the spokesperson wrote.

The manufacturing issue did not appear to have affected negative results, according to the FDA. But those who received a positive result using the Ellume test kit should proceed with caution. If people did not receive a positive test from a different product at the same time, they should not assume that they’ve had COVID-19 or natural immunity from the virus, the FDA said in a statement.

Ellume worked with the FDA to voluntarily remove the affected tests from the market. The company is already producing and shipping new, unaffected test kits to the U.S., the spokesperson said.

Why Is This Error So Dangerous?

According to the FDA, receiving a false positive COVID-19 test can have serious adverse effects, like:

Have COVID-19 Tests Been Recalled Before?Ellume’s at-home test isn’t the only COVID-19 test that the FDA has removed from the market. Some tests have been removed for safety reasons, while others have been removed if the company did not complete an Emergency Use Application request within a reasonable amount of time. Since the start of the pandemic,268 COVID-19 tests have been removed from the market.

Have COVID-19 Tests Been Recalled Before?

Ellume’s at-home test isn’t the only COVID-19 test that the FDA has removed from the market. Some tests have been removed for safety reasons, while others have been removed if the company did not complete an Emergency Use Application request within a reasonable amount of time. Since the start of the pandemic,268 COVID-19 tests have been removed from the market.

What Should You Do if You Used an Ellume Test?

People who are now purchasing or considering purchasing an Ellume test kit should be in the clear, according to Ellume.

According to the FDA, Ellume sent all customers letters about the recall with instructions on how to handle affected products. In the letter, Ellume listed steps like removing the products from shelves, quarantining them from other products, and contacting an Ellume sales representative for further instructions.

To date, the FDA has received 35 reports of false positives and no deaths from the Ellume product.

What This Means For YouIf you received a positive test result from an Ellume COVID-19 Home Test, you shouldn’t assume that you’ve had COVID-19 or natural immunity from the virus, according to the FDA. Check your product’s lot number against theFDA’s database. Visitwww.ellumecovidtest.com/returnfor more instructions or call 1-888-807-1501 or emailproductsupport@ellume.com.

What This Means For You

If you received a positive test result from an Ellume COVID-19 Home Test, you shouldn’t assume that you’ve had COVID-19 or natural immunity from the virus, according to the FDA. Check your product’s lot number against theFDA’s database. Visitwww.ellumecovidtest.com/returnfor more instructions or call 1-888-807-1501 or emailproductsupport@ellume.com.

The information in this article is current as of the date listed, which means newer information may be available when you read this. For the most recent updates on COVID-19, visit ourcoronavirus news page.

1 SourceVerywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.U.S. Food and Drug Administration.Ellume Recalls COVID-19 Home Test for Potential False Positive SARS-CoV-2 Test Results.

1 Source

Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.U.S. Food and Drug Administration.Ellume Recalls COVID-19 Home Test for Potential False Positive SARS-CoV-2 Test Results.

Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.

U.S. Food and Drug Administration.Ellume Recalls COVID-19 Home Test for Potential False Positive SARS-CoV-2 Test Results.

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