Recalls & Warnings
ConsumerLab.com is keeping you informed with current product recalls and warnings.
Posted January 12, 2022
FDA Warns Consumers Not to Use LuSys Laboratories COVID Tests Due to False Results
Update: (03/09/22) On February 17, 2022, the FDA issued a warning letter to LuSys Laboratories, Inc. following an inspection of the firm’s medical device operations in which the agency determined COVID-19 IgG/IgM Antibody Test and COVID-19 Viral Antigen Test products were adulterated because products were sold without approval, clearance, or authorization from the FDA while claiming to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. The agency instructed the company to cease the sale of its unauthorized tests. For more information, see the highlighted link below.
On January 12, 2022, the FDA issued a warning to consumers informing them to stop using LuSys Laboratories COVID-19 Antigen Test (Nasal/Saliva) and LuSys Laboratories COVID-19 IgG/IgM Antibody Test due to a "high risk of false results" when using these tests. Neither test has been authorized, cleared, or approved by the FDA. To date, no saliva-based antigen test has been authorized or approved by the agency.
LuSys Laboratories COVID-19 Antigen Tests (Nasal/Saliva) and COVID-19 IgG/IgM Antibody Tests may also be sold under company names Luscient Diagnostics or Vivera Pharmaceuticals, or with the trade name EagleDx. The tests may have been distributed for use in laboratories or for at-home testing.
According to the agency, both tests may produce false positive or false negative results, which could result in a delayed and proper diagnosis and appropriate treatment.
People who have used these tests and have concerns regarding the results should contact their health care provider.
For more information about authorized COVID tests, including accuracy, where to get them, and our Top Picks among rapid, home antigen tests and home PCR tests, see ConsumerLab's answer to the question How can I get tested for the coronavirus? Which are the best tests?
For more information about the warning, use the link below.
Stop Using LuSys Laboratories COVID-19 Tests: FDA Safety Communication
Warning Letter: Lusys Laboratories, Inc.
See related recalls and warnings:
Unauthorized Rapid Antigen Test Gets FDA Warning
COVID Antibody and Antigen Tests That May Give False Results Recalled