Lusys Laboratories, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 11 (11 Class I)
- 510(k) Clearances
- 0
- Inspections
- 5
- Compliance Actions
- 2
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0717-2022 | Class I | Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114 | January 13, 2022 |
| Z-0718-2022 | Class I | COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies Catalog No: I-111 | January 13, 2022 |
| Z-0716-2022 | Class I | LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Saliva Test) | January 13, 2022 |
| Z-1335-2015 | Class I | Ebola Virus GP-VP IgS, Catalog No. I-124 virus test kit | March 13, 2015 |
| Z-1330-2015 | Class I | Ebola VP-40 IgG/IgM (Blood Serum/Plasma/Cassette), Catalog No. I-102 Materials Provided: 1. Test | March 13, 2015 |
| Z-1334-2015 | Class I | Ebola Virus Antigen Blood, Catalog No. I-123 (A) Materials Provided: 1. Test Device in foil pou | March 13, 2015 |
| Z-1329-2015 | Class I | Ebola GP IgX Blood, Serum, Plasma, Cassette, Catalog No. I-101 Materials Provided: 1. Test Devic | March 13, 2015 |
| Z-1328-2015 | Class I | Ebola IgX VP-40 Serum/Plasma/Blood Cassette, Catalog No. I-100 Materials Provided: 1. Test Devic | March 13, 2015 |
| Z-1331-2015 | Class I | Ebola GP IgM Blood (Blood Serum/Plasma/Cassette), Catalog No. I-103 virus test kit | March 13, 2015 |
| Z-1333-2015 | Class I | Ebola Virus Antigen Nasal , Catalog No. I-123 (B) Materials Provided: 1. Test Device in foil po | March 13, 2015 |
| Z-1332-2015 | Class I | Ebola Accessories assembled, self-contained package, Catalog No. I-104 virus test kit | March 13, 2015 |