The FDA issued a warning Tuesday the potential for false positive results with certain lots of the Ellume COVID-19 Home Test due to a recently identified manufacturing issue.

COVID-19 test kit maker Ellume is recalling some at-home tests after learning that they were reporting a higher-than-expected rate of false positive results.

This undated photo provided by Ellume shows a self-administered rapid coronavirus at home test kit developed by Australian manufacturer Ellume. U.S. regulators on Tuesday, Dec. 15, 2020, allowed emergency use of the first rapid coronavirus test that consumers can buy without a prescription to test themselves entirely at home. (Ellume via AP)WASHINGTON – The first home test for COVID-19 that doesn't require a prescription will soon be on U.S. store shelves. U.S. officials Tuesday authorized the rapid coronavirus test which can be done entirely at home. Australian manufacturer Ellume said it expects to produce 3 million tests next month before ramping up production over the first half of 2021.