A recall of about 2 million at-home COVID-19 test kits made by the Australian-based biotech company Ellume has been issued by the U.S. Food and Drug Administration.
The agency recalled the tests for producing "false positive" results due to a manufacturing defect.
This is not the first time that the FDA has recalled tests from Ellume. In October, the company made the FDA aware of almost 200,000 tests declared faulty for the exact same reason.
The additional tests found to be defective were manufactured by Ellume between Feb. 24, 2021, and Aug. 11, 2021. The company announced that there had been 35 false-positive results from the test so for, the FDA reported.
The test recall is the most serious by the FDA, known as a Class I recall.
Ellume's CEO, Sean Parsons, posted an apology to those who received a false positive test on the company's website. In addition, he shared that the company is working to correct any future issues like this.
"You have my personal commitment that we have learned from this experience, we have implemented additional controls to ensure our product meets our high quality standards and we are going to do everything in our power to regain your trust," Parsons said in the statement.
The company had agreed on a deal with the Biden administration worth $231.8 million earlier this year to increase the availability of tests in the U.S.
Its over-the-counter nasal swab test can be purchased at pharmacies or grocery stores across the country.
To fight the ongoing shortage of at-home tests, NPR reported that the White House announced last month that it would be allocating $1 billion in funds to increase the availability of at-home tests.
Related
