medical Class I Updated 2022-03-16

Lusys Laboratories, Inc. recalls LuSys 2nd Generation of COVID-19 Viral Antigen Test For all

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Part Number: I-114(S) Lot Numbers: All Lots due to not having an authorized Emergency Use Authorization (EUA)
View official government recall

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