At-Home COVID 19 Test Kit Recalled By The FDA

November 15, 2021

The Food and Drug Administration has issued a recall on the at-home Covid 19 test by Ellume Health. The Ellume at-home Covid test is an antigen test and uses a swap to take the sample from the nose.

The FDA says the test kit has a high false-positive test result rate that is not acceptable. The false-positive result could have a negative impact on a person’s health. For example, unnecessary isolation, side effects from unnecessary COVID 19 treatment, and delayed diagnosis and treatment for the illness you actually have that could be more life-threatening than COVID 19.

The FDA said the test kit’s negative results have been reliable and are not an issue.

If you have one of the test kits or for more information if you have used this test click here.