- For Immediate Release:
- October 08, 2021
The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic:
- On Tuesday October 5, the FDA issued a safety communication to alert test users, caregivers, health care personnel and the public of the potential for false positive results with certain lots of the Ellume COVID-19 Home Test due to a recently identified manufacturing issue. A “false positive” is a test result that says a person has the virus when they do not actually have it. Negative test results do not appear to be affected by the manufacturing issue. The FDA is not aware of any confirmed serious injuries or deaths related to the false positive results with the affected Ellume COVID-19 Home Tests at this time. The FDA is working with Ellume to assess Ellume’s additional manufacturing checks and other corrective steps to address the reason for the manufacturing issue and help ensure that the issue is resolved.
- Testing updates:
- As of today, 415 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 290 molecular tests and sample collection devices, 89 antibody and other immune response tests and 36 antigen tests. There are 65 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one molecular prescription at-home test, three antigen prescription at-home tests, eight antigen over-the-counter (OTC) at-home tests and two molecular OTC at-home tests.
- The FDA has authorized 16 antigen tests and eight molecular tests for serial screening programs. The FDA has also authorized 642 revisions to EUA authorizations.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.