FDA recall Z-0183-2022
ELLUME LTD · Class I · device
Product
Ellume COVID-19 Home Test
Reason for recall
Due to a higher rate of false positive test results.
Distribution
U.S.: MN, NY, PA, RI, UT, WA. O.U.S.: Not provided
Key facts
- Status
- Ongoing
- Initiation date
- 2021-10-01
- Report date
- 2021-11-17
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- East Brisbane, N/A, Australia
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0183-2022