Lusys Laboratories, Inc. FDA Recalls

3 recalls on file across devices, 3 of them Class I and 3 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Nasal Swab Test)Class IJan 13, 2022COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapi	COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, cleared, or approv	Class IDevices	Jan 13, 2022
LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Saliva Test)Class IJan 13, 2022COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapi	COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, cleared, or approv	Class IDevices	Jan 13, 2022
COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies Catalog No: I-111Class IJan 13, 2022COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapi	COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, cleared, or approv	Class IDevices	Jan 13, 2022