The U.S. Food and Drug Administration announced the recall of 2.2 million home COVID-19 tests made by Ellume, the first company to get FDA approval for over-the-counter COVID tests, due to “higher-than-acceptable false positive test results.” The recall is an expansion of last month’s recall of 200,000 kits for the same issue.
About 35 false positives through the Ellume COVID-19 Home Test were reported to the FDA, with no deaths reported, the agency said. But false positives could lead to negative outcomes such as getting unneeded COVID-19 treatment from a health care provider or a delayed diagnosis for the person’s actual illness, the FDA added.
The FDA said that the reliability of negative test results aren’t impacted by the issue. But people who have bought an Ellume home COVID-19 test should check the product by entering the lot number at this Ellume website, which will determine whether the consumer has one of the impacted tests. The lot number is found on a sticker on the side of the product carton.
If a consumer received a positive test within the last two weeks by using one of the affected lots, they should contact their health care provider, the agency said.
The “incidence of false positives is limited to specific lots,” Ellume CEO Dr. Sean Parsons said in a statement. He also apologized to people who received false positives through the test kit “for any stress or difficulties they may have experienced.”
In a statement sent to CBS MoneyWatch, Ellume said it has identified the root cause of the problem and implanted additional controls. “We are already producing and shipping new product to the U.S.,” it added.
It added, “Importantly, not all of the positive results of the affected tests were false positives, and negative results were not affected by this issue.”
The FDA said the Ellume case is a Class I recall, which it said is the most serious type. “Use of these tests may cause serious adverse health consequences or death,” the agency said in the statement.
The recall comes at a time when it’s not easy to find at-home COVID-19 tests. Many pharmacies are out of stock, and if they are available, the tests will cost about $24 a pair — an expensive outlay for many consumers who need frequent testing.
While many consumers would undoubtedly like to be able to test for COVID-19 at home, the shortages and costs mean that many check their health status only when traveling or attending a special event. But that may change in the next few months, with the Biden administration in September announcing it would invest $1 billion to expand the supply of at-home COVID-19 tests.
The Ellume COVID-19 Home Test is an antigen test that works by detecting proteins from the SARS-CoV-2 virus, which causes COVID-19. The over-the-counter test requires consumers to swab the inside of their noses.
The FDA said the recalled home tests were manufactured between February 24 to August 11, and distributed between April 13 to August 26.