--- title: "Lusys Laboratories, Inc. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Lusys Laboratories, Inc. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/lusys-laboratories-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Lusys Laboratories, Inc. recall records **3** reported ongoing 3 records in this archive. Latest source date Jan 13, 2022. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Jan 13, 2022 FDA device enforcement ### [LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Saliva Test)](https://isitonrecall.com/recall/fda-device-z-0716-2022-lusys-2nd-generation-of-covid-19-viral-antigen-test-for-all-mutant-variety-cat-i-114-saliva-test/) 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. Class I Reported ongoing Distribution: 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 Cons... [Official source for LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Saliva Test)](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0716-2022%22) Jan 13, 2022 FDA device enforcement ### [Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Nasal Swab Test)](https://isitonrecall.com/recall/fda-device-z-0717-2022-luscient-diagnostics-2nd-generation-of-covid-19-viral-antigen-test-for-all-mutant-variety-cat-i-114/) 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. Class I Reported ongoing Distribution: 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 Cons... [Official source for Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0717-2022%22) Jan 13, 2022 FDA device enforcement ### [COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies Catalog No: I-111](https://isitonrecall.com/recall/fda-device-z-0718-2022-covid-19-igg-igm-antibody-test-for-detection-of-covid-19-igg-and-igm-antibodies-catalog-no-i-111/) 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. Class I Reported ongoing Distribution: 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 Cons... [Official source for COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies Catalog No: I-111](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0718-2022%22) ## Reasons in these listed records - 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. These examples come from this result page and are not a ranking of every recall reason. ## Checking Lusys Laboratories, Inc. ### Is there a recall on lusys laboratories, inc. right now? This archive contains 3 records, including 3 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Lusys Laboratories, Inc.](https://isitonrecall.com/check/?q=Lusys%20Laboratories%2C%20Inc.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)