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Empowered Diagnostics Recalls
2 recalls on record · February 9, 2022 to February 9, 2022 · Medical Devices
February 9, 2022Medical DevicesFDA
Empowered Diagnostics LLC recalls ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60
Hazard: COVID test kits were offered for sale and distributed to consumers in the United States without marketing approval, clearance, or authorization from FDA.
February 9, 2022Medical DevicesFDA
Empowered Diagnostics LLC recalls CovClear COVID-19 Rapid Antigen Test, ATG 900-031
Hazard: COVID test kits were offered for sale and distributed to consumers in the United States without marketing approval, clearance, or authorization from FDA.