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FDAJanuary 13, 2022device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

lusys laboratorieslusys

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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