Stop Using LuSys Laboratories COVID-19 Tests – FDA Safety Communication

U.S. Food and Drug Administration sent this bulletin at 01/11/2022 01:10 PM EST

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FDA - Center for Devices and Radiological Health

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Stop Using LuSys Laboratories COVID-19 Tests - FDA Safety Communication

Today, the U.S. Food and Drug Administration (FDA) issued a safety communication warning people to stop using the LuSys Laboratories COVID-19 Antigen Test (Nasal/Saliva) and the LuSys Laboratories COVID-19 IgG/IgM Antibody Test. The performance of these tests has not been adequately established and the FDA believes there is likely a high risk of false results when using these tests. Neither test has been authorized, cleared, or approved by the FDA for distribution or use in the United States.

The LuSys Laboratories COVID-19 Antigen Tests (Nasal/Saliva) and COVID-19 IgG/IgM Antibody Tests may also be sold under the company names Luscient Diagnostics or Vivera Pharmaceuticals, or with the trade name EagleDx.

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This safety communication provides:

  • Details on the issue and the FDA’s actions.
  • Recommendations for test users, caregivers, and health care personnel.
  • Instructions for reporting problems with tests to the FDA.

Questions?

If you have questions about this safety communication, contact the Division of Industry and Consumer Education (DICE).