CovClear COVID-19 Rapid Antigen Test, ATG 900-031
FDA Recall #Z-0480-2022 — Class I — December 22, 2021
Product Description
CovClear COVID-19 Rapid Antigen Test, ATG 900-031
Reason for Recall
COVID test kits were offered for sale and distributed to consumers in the United States without marketing approval, clearance, or authorization from FDA.
Recalling Firm
Empowered Diagnostics LLC — Pompano Beach, FL
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
284,575 units
Distribution
US Nationwide Distribution
Code Information
All lots
Status
Completed
Voluntary / Mandated
Voluntary: Firm initiated