Empowered Diagnostics LLC
Empowered Diagnostics LLC appears in FDA public data with 2 recalls — including 2 Class I (most serious) —, 0 510(k) clearances, 0 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-0481-2022, Class I) was initiated on December 22, 2021.
Summary
- Total Recalls
- 2 (2 Class I)
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0481-2022 | Class I | ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60 | December 22, 2021 |
| Z-0480-2022 | Class I | CovClear COVID-19 Rapid Antigen Test, ATG 900-031 | December 22, 2021 |