Lower riskMedical device recall · FDA · Published January 13, 2022
Lusys Luscient Diagnostics 2: Not FDA-approved for U.S. COVID-19 Tests
Lusys recalls its 2nd Gen COVID-19 antigen test kits as they lack U.S. FDA authorization. These kits may not be reliable for detecting the virus in the U.S. market.
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.
Take action
Contact the company
📍Recalling firmLusys Laboratories, Inc.7220 Trade St Ste 338 · San Diego, CA 92121-2324
✎ GovInfoNow plain-language explainer
Lusys Laboratories is recalling its Luscient Diagnostics 2nd Generation COVID-19 Viral Antigen Test kits because they are not authorized for use in the U.S. This means the tests could give inaccurate results and are unsafe to use without proper regulatory approval. Read more at govinfonow.com/recall/61269-lusys-luscient-diagnostics-2-not-fda-approved-for-u-s.
“Lusys Luscient Diagnostics 2: Not FDA-approved for U.S. COVID-19 Tests.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61269-lusys-luscient-diagnostics-2-not-fda-approved-for-u-s. Based on FDA recall #Z-0717-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0717-2022%22&limit=1).
Lusys Laboratories, Inc. voluntarily recalled its Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test kits on Jan. 13, 2022, according to the FDA. The agency announced that the products were not authorized for marketing in the U.S.
How to tell if you have it
Brand: Lusys
Product: Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Nasal Swab Test)
Part Number: I-114(N)
Lot Numbers: All Lots
Quantity: 90,849 kits
The hazard
The recalled COVID-19 test kits, including Antibody Rapid Test and Antigen Rapid Test kits, are not authorized, cleared, or approved for marketing and/or distribution in the U.S. The FDA classified this as a Class I recall.
Context
GovInfoNow's records show other recent recalls of similar products include Covidien Mon-a-Therm Temperature Probe Recall (2026-04-23), GET TESTED International AB: 2-in-1 Trichomonas/Gardnerella Test Recall (2025-11-03), and Vivoo pH Test Recall (2025-11-22).
How to tell if you have this one
Check for the product name 'Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test' and part number I-114(N). All lots are affected due to the lack of FDA authorization.
Brand
Lusys
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class I
Status
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 Consignee Listing
Recall number
Product, codes & lots
Quantity
Z-0716-2022
LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Saliva Test); Part Number: I-114(S) Lot Numbers: All Lots due to not having an authorized Emergency Use Authorization (EUA)
14,745 kits
Z-0717-2022
Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Nasal Swab Test); Part Number: I-114(N) Lot Numbers: All Lots due to not having an authorized Emergency Use Authorization (EUA)
90,849 kits
Z-0718-2022
COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies Catalog No: I-111; Part Number: I-111 Lot Numbers: All Lots due to not having an authorized Emergency Use Authorization (EUA)
33,955 kits
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the product name and part number I-114(N) on the test kit packaging.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 6 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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 Consignee Listing” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Nevada, North Carolina, Ohio, Tennessee, Texas.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0717-2022 (January 13, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0717-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.