Jacquelyn Martin / AP
The US Food and Drug Administration has announced a recall of approximately 2 million COVID-19 test kits for the home of the Australian biotech company Ellume.
The federal regulator says the test kits may give “false positive” results due to a manufacturing defect. The company first informed the FDA in October that some batches were defective.
On Wednesday, the FDA said it had identified additional lots affected by the manufacturing defect. The flawed tests were made by Ellume between February 24, 2021 and August 11, 2021. To date, 35 false positive tests have been reported to the FDA from these tests.
The FDA described the Ellume test recall as “the most severe type” known as the Class I recall.
Earlier this year, the Biden government signed a $ 231.8 million contract with Ellume to increase the availability of the tests in the US market. Ellume’s contract with the Department of Defense and the Department of Health helped fund the company’s first facility in the country, which opened in Frederick, Maryland in May.
The over-the-counter nasal swab tests can be purchased from a pharmacy or grocery store and taken at home. Home kits – like Ellume’s – detect small pieces of the virus that causes COVID-19 They are believed to give fairly reliable results in about 15 minutes, especially for those who are symptomatic.
The FDA and Ellume say the reliability of negative results was not affected by the problem identified in the flawed tests. In a statement posted on the company’s website, founder and CEO Dr. Sean Parsons on those who received a false positive.
“[W]We understand that trust is central to the fulfillment of our corporate purpose, and we recognize that this incident may have shaken the confidence of some of those who trusted Ellume to manage their health and take some control over their lives along the way regaining this pandemic, “Parsons said.
Ellume says it fixed the manufacturing problem, and federal regulators say they are monitoring the company’s efforts as it progresses.
“The FDA continues to work with Ellume to evaluate the company’s corrective actions, the regulator announced.
Home over-the-counter test kits have grown in popularity as the pandemic continued and federal agencies granted emergency approval to tests for a number of companies.
In March, the FDA announced plans to streamline the home test approval process. The agency updated this process in October.
Also last month, the White House announced an additional $ 1 billion allocation for home testing to help alleviate an ongoing national shortage.