At-Home COVID Tests Being Recalled Due to False-Positive Results

Several at-home COVID-19 tests are being recalled after it was discovered that they were incorrectly providing false-positive results.

In a statement, Ellume, the manufacturer of the tests, said, "In recent weeks, we noted an increased chance that Ellume COVID-19 Home Tests from specific lots may provide an incorrect positive result. Following a thorough investigation, we isolated the cause and confirmed that this incidence of false positives is limited to specific lots."

According to Ellume, the company has worked with the U.S. Food and Drug Administration (FDA) to issue the voluntary recall and remove the affected at-home test kits from the market. The statement said that the tests included in the recall 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.

Ellume did not announce the specific number of tests that are included in the recall, but a full list of lot numbers that have been recalled can be found here.

In a statement, Ellume CEO and Founder Sean Parsons said, "At Ellume, 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 to take back a bit of control of their lives during this pandemic."

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."

In a statement sent to Newsweek, Ellume said that it has "implemented additional controls and is continuing to work on resolving the issue that led to this recall."

The statement also noted that some of the tests included in the recall were distributed to the U.S. Department of Defense "to be further distributed to community health programs as part of the National Strategy for the COVID-19 Response and Pandemic Preparedness Plan."

Customers that purchased an at-home COVID-19 test kit from Ellume that was included in the recall are directed to request a return from the company by going to EllumeCovidTest.com/return and filling out the form.

"We apologize for the complexity of the form but we are required to track and report false positive results to the FDA," Ellume said on the return website.

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

"By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drugstores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes," former FDA Commissioner Stephen Hahn said in December.

COVID-19 Test
An at-home COVID-19 test was recalled due to incorrectly providing users with a false-positive result. Above, a Health Care Worker seals a coronavirus swab after testing at the Pro Health Urgent Care coronavirus testing site on April 30, 2020 in Wantagh, New York. Al Bello/Getty