Update time: November 11, 2021 / 7:12 PM / MoneyWatch
The U.S. Food and Drug Administration announced the recall of 2.2 million home COVID-19 tests conducted by Ellume. The company was the first company to receive FDA approval for over-the-counter COVID-19 testing because "false positive test results are higher than acceptable level". "This recall is an expansion of the 200,000 kits recalled for the same issue last month.
The agency stated that about 35 false positives were reported to the FDA through the Ellume COVID-19 home test, and no deaths were reported. But the FDA added that false positives may lead to negative results, such as obtaining unwanted COVID-19 treatment from a healthcare provider or delaying the diagnosis of the person's actual illness.
The FDA stated that the reliability of negative test results is not affected by this issue. But people who have purchased the Ellume home COVID-19 test should check the product by entering the batch number on this Ellume website, which will determine whether the consumer has one of the affected tests. The lot number is located on the sticker on the side of the product carton.
The agency stated that if consumers have had a positive test using one of the affected batches in the past two weeks, they should contact their healthcare provider.
"The incidence of false alarms is limited to specific batches," Ellume CEO Dr. Sean Parsons said in a statement. He also apologized to those who received false positives through the test suite "for any pressure or difficulties they may encounter."
In a statement sent to CBS MoneyWatch, Ellume stated that the root cause of the problem has been determined and additional control measures have been implanted. "We are already producing new products and shipping them to the United States," it added.
It added: "It is important that not all positive results of the affected tests are false positives, and negative results are not affected by this issue."
The FDA stated that the Ellume case is a Class I recall, the most serious type. The agency said in a statement: "The use of these tests may lead to serious adverse health consequences or death."
The recall was carried out when it was not easy to find COVID-19 testing at home. Many pharmacies are out of stock. If they are available, the price for each pair of tests is about $24-an expensive expense for many consumers who need frequent tests.
Although many consumers undoubtedly want to be able to test for COVID-19 at home, the shortage and cost means that many consumers only check their health when traveling or participating in special events. But this situation may change in the coming months. The Biden administration announced in September that it would invest US$1 billion to expand the supply of home COVID-19 tests.
The Ellume COVID-19 Home Test is an antigen test that works by detecting the protein of the SARS-CoV-2 virus, which causes COVID-19. Over-the-counter tests require consumers to wipe the inside of the nose.
The FDA stated that the recalled home tests were manufactured between February 24 and August 11 and distributed between April 13 and August 26.
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First published on November 11, 2021 / 1:01 PM
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