In a statement urging people to stop using rapid antigen tests from LuSys Laboratories, the agency said it had not adequately established the performance of the company’s Antigen Test (Nasal/Saliva) or its IgG/IgM Antibody Test.
“The FDA believes there is likely a high risk of false results when using these tests,” the statement said.
“Neither test has been authorised, cleared, or approved by the FDA for distribution or use in the United States.”
The tests may also be sold under the alternate names Luscient Diagnostics or Vivera Pharmaceuticals, or with the trade name EagleDx, the FDA said.
The agency said the tests have been distributed for use in both a laboratory setting at for at-home use, adding that any healthcare provider that has purchased or used the tests to re-test anyone “questionable results” from the past two weeks. Anyone who has used the kits at home is advised to contact their health care providers.
The FDA previously warned using LuSys Laboratories unapproved tests, recalling 2,000 Ebola Virus One-Step Test Kits in 2015.
Last year, the agency warned about Covid-19 tests from Innova Medical Group and Lepu Medical Technology, which delivered unapproved kits to pharmacies and healthcare providers.