INDIANAPOLIS — More than two million at-home COVID-19 tests are being recalled due to high false-positive results.
The FDA says it's a class one recall, which is the most urgent type. The tests are from the brand, Ellume.
Regulators say false positives could lead to a delayed diagnosis or treatment of the actual cause of a person's illness.
There have been 35 reports of false positives, and no deaths have been reported.
The FDA says the reliability of negative test results is not affected.
The tests were manufactured between February 24 and August 11 and were distributed from April 13 to August 26.
Those who have received a positive result with an Ellume test are advised to have a follow-up test.
