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Recall Observatory FDA recall evidence

Device product

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

Z-0717-2022

January 13, 2022

Class I

Product summary

Firm
Lusys Laboratories, Inc.
Event
Event 89539
Status
Ongoing
Classification
Class I
Quantity
90,849 kits
Official record key
device-enforcement:Z-0717-2022

Official wording

Reason: 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.

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

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.