Versea Diagnostics LLC
Versea Diagnostics LLC appears in FDA public data with 4 recalls, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2410-2021, Class II) was initiated on July 27, 2021.
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2410-2021 | Class II | Status COVID-19/Flu Rapid Immunoassay for Direct Detection and Differential Diagnosis of SARS-CoV-2, | July 27, 2021 |
| Z-2408-2021 | Class II | FaStep COVID-19 IgG/IgM Rapid Test Device Qualitative detection and differentiation of IgM and IgG | July 27, 2021 |
| Z-2407-2021 | Class II | CareStart COVID-19 Antigen Rapid Diagnostic Test for the detection of SARS-CoV-2 Antigen Qualitativ | July 27, 2021 |
| Z-2409-2021 | Class II | Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Qualitative detection and d | July 27, 2021 |