More than 2 million at-home COVID-19 tests are being recalled due to a high rate of false-positive test results.
The U.S. Food and Drug Administration says it is a Class One Recall, the most urgent type.
The tests are from the brand Ellume. According to the Ellume website, the tests were available online and through retailers including Amazon, CVS Pharmacy, and Walmart.
Regulators are concerned that false-positive test results 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. No deaths have been reported.
The FDA says the reliability of negative test results is not affected.
The recalled tests were manufactured between February 24 and August 11; they were distributed from April 13 to August 26.
If you received a positive result with an Ellume test, you are advised to take a follow-up test through a different method.
In February, the Biden administration awarded Ellume nearly $232 million to produce at-home tests.