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First FDA-approved over-the-counter available COVID tests recalled following false positives

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After a higher-than-expected rate of false positives, the first firm to receive FDA approval to market its over-the-counter COVID tests is recalling over 200,000 of the kits sold by retailers such as Amazon, CVS, Target, and Walmart.

The recall affects 43 batches shipped to retailers and the Department of Defense between April and August, according to a notification placed on Ellume’s website. The specific lots indicated higher positive rates than found in clinical studies, prompting the Brisbane, Australia-based company to investigate the problem, which it stated was being worked on.

“Following a thorough investigation, we isolated the cause and confirmed that this incidence of false positives is limited to specific lots,” Dr. Sean Parson, Ellume’s CEO and founder said in a statement.

“We recognize that this incident may have shaken the confidence of some of those who trusted Ellume to help them manage their health and take back a bit of control of their lives during this pandemic,” added Parson, who apologized for “any stress or difficulties” to those who falsely tested positive.

There were about 427,000 tests in the lots being recalled, with about 195,000 unused and subject to the recall, the company relayed to CBS MoneyWatch in an emailed statement. Approximately 160,000 of the tests produced negative results considered reliable, while about 42,000 produced positive results, “which include both true positives and false positives,” according to the company.

Ellume is notifying those affected by the recall, and those who try to use the affected tests will be told in the company’s app that the test has been recalled and disabled. 

People who purchased an Ellume kit can check whether it’s part of the recall here, as well as request a replacement test. The company can also be reached Monday through Friday, 9 a.m. to 5 p.m. EST, at 1(888) 807-1501. 

The FDA flagged the issue on Tuesday, saying it was working with Ellume to make sure the manufacturing issue is resolved. 

Ellume’s rapid antigen test in December became the first at-home test to receive emergency use authorization from the FDA. The agency on Monday authorized a new at-home antigen test, ACON Laboratories’ Flowflex. 

The Biden administration last month said it was partnering with retailers including Amazon, Kroger and Walmart to make the at-home rapid tests less costly and easier to get. The White House in recent days said it would invest another $1 billion in putting more of the tests on the market.

Image Credit: Getty

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