East Brisbane, N/A, Australia
ELLUME LTD recalls
1 recall recorded since 2018, most recently on 1 October 2021. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)1
Ongoing Class I Medical devices
- Recall started
- 1 October 2021
- Reason
- Due to a higher rate of false positive test results.
- Distribution
- U.S.: MN, NY, PA, RI, UT, WA. O.U.S.: Not provided
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0183-2022
- Ellume COVID-19 Home Test
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.