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Recall Observatory FDA recall evidence

Device product

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

Z-0718-2022

January 13, 2022

Class I

Product summary

Firm
Lusys Laboratories, Inc.
Event
Event 89539
Status
Ongoing
Classification
Class I
Quantity
33,955 kits
Official record key
device-enforcement:Z-0718-2022

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-111 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.