The Food and Drug Administration has issued a voluntary recall on some at-home COVID-19 tests.
The FDA has issued a recall on 2.2 million Ellume COVID-19 tests. Ellume received $232 million in federal funding earlier this year to help make the tests. The recall has been issued due to higher-than-acceptable false positive test results for COVID-19, according to the FDA notice.
The tests were manufactured between February 24th and August 11th and have been sold between April 13th and August 26th all throughout the United States.
The FDA had issued an Emergency Use Authorization on December 15th of last year for use of the test, and re-upped the authorization on February 11th. The recall is an expansion of a recall issued in early October for 200,000 test kits of the same issue. According to the recall notice, approximately 35 false positives have been reported due to the test.
A list of the affected lot numbers of the test can be found on the FDA’s recall notice on its website. The FDA says that a letter has been sent to all impacted customers on October 1st to stop the sale and report any issues. For individuals who may have received a positive test from the affected lot numbers, the FDA says those individuals should to contact their health care provider, urgent care facility, or other COVID-19 testing site and request a COVID-19 molecular diagnostic test to confirm the positive test result.
The FDA says that no deaths have occurred due to the tests. However, they caution that some issues that could result from the recalled product could be getting unnecessary treatment and a potential delayed diagnosis for actual illness. More information can be found by emailing firstname.lastname@example.org or by calling 1-888-807-1501.