Lusys Laboratories, Inc.: COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, cleared, or approved for marketing and/or distribution in the U.S.

Agency Publication Date: March 10, 2022

Affected Products

Product: LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Saliva Test)

Part Number: I-114(S) Lot Numbers: All Lots due to not having an authorized Emergency Use Authorization (EUA)

Lot Numbers:

Numbers

Product: Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Nasal Swab Test)

Part Number: I-114(N) Lot Numbers: All Lots due to not having an authorized Emergency Use Authorization (EUA)

Lot Numbers:

Numbers

Product: COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies Catalog No: I-111

Part Number: I-111 Lot Numbers: All Lots due to not having an authorized Emergency Use Authorization (EUA)

Lot Numbers:

Numbers

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89539

Status: Active

Manufacturer: Lusys Laboratories, Inc.

Manufactured In: United States

Units Affected: 3 products (14,745 kits; 90,849 kits; 33,955 kits)

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Sources: FDA iRES · Raw API Response

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Affected Products

Product: LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Saliva Test)

Part Number: I-114(S) Lot Numbers: All Lots due to not having an authorized Emergency Use Authorization (EUA)

Lot Numbers:

Numbers

Product: Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Nasal Swab Test)

Part Number: I-114(N) Lot Numbers: All Lots due to not having an authorized Emergency Use Authorization (EUA)

Lot Numbers:

Numbers

Product: COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies Catalog No: I-111

Part Number: I-111 Lot Numbers: All Lots due to not having an authorized Emergency Use Authorization (EUA)

Lot Numbers:

Numbers