COVID home test kits recalled over false positives in United States

Australian digital diagnostics company Ellume says it has recalled several COVID-19 home test kits over false-positive results in the United States. The company said in recent weeks it had taken the step after noting an “increased chance that Ellume COVID-19 Home Tests from specific lots may provide an incorrect positive result.” Ellume said after a thorough investigation, it identified the cause and “confirmed that this incidence of false positives is limited to specific lots.”

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Some of the tests included in the recall were distributed to the US Department of Defense (DoD) “to be further distributed to community health programs as part of the National Strategy for the COVID-19 Response and Pandemic Preparedness Plan,” Ellume said in a statement to Newsweek.

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Ellume landed a $231.8 million contract with the DoD  in February 2021 to supply its rapid COVID-19 Home Test to the US market, according to Packaging News.

In  a statement, the company said it has worked with the Food and Drug Administration (FDA) to issue the voluntary recall which included tests that were distributed from April 2021 to August 2021.

“Importantly, the reliability of negative results is unaffected by this issue and are not included within this recall,” the company’s statement said.

The company issued a full list of lot numbers that have been recalled on its website.

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Ellume CEO and Founder Sean Parsons admitted the incident may have shaken the confidence of its customers.

Parsons continued, “To those individuals, I offer my sincere apologies—and the apologies of our entire company—for any stress or difficulties they may have experienced because of a false positive result.”

Ellume said that it has “implemented additional controls and is continuing to work on resolving the issue that led to this recall.”

Ellume was one of the first at-home COVID-19 tests to receive emergency use authorization from the FDA in December.