More than 2 million take-home COVID-19 test kits have been recalled over a “potential false positive,” according to a report from the Food and Drug Administration.
In an announcement on Nov. 10, the FDA provided an update regarding the Oct. 5 recall of COVID-19 at-home tests. Ellume, an Australian medical test diagnostics company, has now recalled more than 2 million out of 3.5 million tests sent to the United States last month, the New York Times reported.
Dr. Sean Parsons, the CEO and founder of the company, assured people that after investigating the recalled products, they had “isolated the cause” and confirmed the false positives were limited to “specific product lots,” according to a press statement.
WASHINGTON STATE ORDERS RECALL OF 12,000 CORONAVIRUS TESTS OVER ‘QUALITY CONTROL’ ISSUES
The recall is classified as a “Class I recall,” the most serious classification, according to another statement from the FDA. Continued use of the products can lead to “serious adverse health consequences or death,” the statement added.
A spokeswoman for Ellume confirmed to the Washington Examiner the company had “investigated the issue, identified the root cause, implemented additional controls” and is “producing and shipping new product to the U.S.”
The announcement of the expanded recall of the company’s test kits follows an Oct. 5 recall when 427,000 products had been reported to be affected.
“We understand that trust is central to fulfilling our purpose as a company,” Parsons said in his 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 to take back a bit of control of their lives during this pandemic.”
Today, the @US_FDA identified a Class I Recall, the most serious type of recall: Ellume recalls #COVID19 Home Test for potential false positive SARS-CoV-2 test results. Find out more: https://t.co/trYCnubKH7 pic.twitter.com/L6xqzFXk8G
— FDA Medical Devices (@FDADeviceInfo) November 10, 2021
CLICK HERE TO READ MORE FROM THE WASHINGTON EXAMINER
“To be clear, the FDA notice did not represent a new recall. This was simply a follow-up to the agency’s announcement last month of Ellume’s voluntary recall in order to provide an update on the recall’s classification and additional lots impacted,” a spokesperson with Ellume said in a statement provided to the Washington Examiner.
