FDA-Device2022-03-16Class I
COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies Catalog No: I-111
Lusys Laboratories, Inc.
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.
Sold states
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
Affected count
33,955 kits
Manufactured in
7220 Trade St Ste 338, N/A, San Diego, CA, United States
Products
COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies Catalog No: I-111
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0718-2022Don't want to check this manually?
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