Sauder Schelkopf is investigating a potential class action lawsuit related to the recall of at-home coronavirus (COVID-19) tests manufactured by LuSys Laboratories.

According to the FDA: 

Device Use

The LuSys Laboratories COVID-19 Antigen Test uses a nasal swab, or a saliva (spit) sample intended to detect proteins, called antigens, on the SARS-CoV-2 virus.

The LuSys Laboratories COVID-19 IgG/IgM Antibody Test uses serum, plasma, or blood samples to look for antibodies produced by a person’s immune system in response to SARS-CoV-2, the virus that causes COVID-19, suggesting a recent or previous infection. Antibody tests should not be used to diagnose or exclude an active COVID-19 infection.

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, Vivera Pharmaceuticals, or with the trade name EagleDx.

Reason for Recall  

LuSys Laboratories is recalling these tests because they do not have an Emergency Use Authorization, 510(k), or PMA and therefore cannot be legally marketed and distributed in the United States. In addition, LuSys Laboratories did not provide appropriate validation data to show that the tests can perform accurately.  This means there is a risk of potential false negative, false positive, and misinterpretation of results from these tests.

LuSys Laboratories has received no complaints or reports of injuries, deaths, or adverse events.   

Experience Matters

Sauder Schelkopf is a nationally recognized class action and personal injury law firm. The firm’s partners currently serve as court appointed lead counsel in courts across the country and have been selected by the National Trial Lawyers Association as some of the Top 100 Trial Lawyers in Pennsylvania since 2012. The attorneys at Sauder Schelkopf have recovered over $500 million on behalf of their clients and class members.

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