Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test… — Class I medical device recall Z-0717-2022
Ongoing recall by Lusys Laboratories, Inc., reported 2022-03-16, distributed nationwide. COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, cleared, or approv
| Recall number | Z-0717-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lusys Laboratories, Inc., San Diego, CA, United States |
| Recall initiated | 2022-01-13 |
| Classified | 2022-03-10 |
| Reported by FDA | 2022-03-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CN, MX |
| Quantity | 90,849 kits |
| Model numbers | I-114 |
Product
Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Nasal Swab Test)
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0717-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.