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

Recalled March 16, 2022 · FDA recall Z-0717-2022 · Lusys Laboratories

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. · FDA Class I

Units

90,849 kits

Sold at

Worldwide - US Nationwide distribution in the states of CA, NC, NV, OH, TN and TX. The countries of Canada, China, and Mexico. Pending additional information for a complete Consignee Listing

Description

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.

Product

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

Manufacturer(s)

Lusys Laboratories, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →