ELLUME LTD
ELLUME LTD appears in FDA public data with 1 recall — including 1 Class I (most serious) —, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0183-2022, Class I) was initiated on October 1, 2021.
Summary
- Total Recalls
- 1 (1 Class I)
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0183-2022 | Class I | Ellume COVID-19 Home Test | October 1, 2021 |