Pompano Beach, FL, United States
Empowered Diagnostics LLC recalls
1 recall recorded since 2018, most recently on 22 December 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)1
Completed Class I Medical devices
- Recall started
- 22 December 2021
- Reason
- COVID test kits were offered for sale and distributed to consumers in the United States without marketing approval, clearance, or authorization from FDA.
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0480-2022, Z-0481-2022
- CovClear COVID-19 Rapid Antigen Test, ATG 900-031
- ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60
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.