Empowered Diagnostics LLC FDA Recalls

2 recalls on file across devices, 2 of them Class I and 0 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
CovClear COVID-19 Rapid Antigen Test, ATG 900-031Class IDec 22, 2021COVID test kits were offered for sale and distributed to con	COVID test kits were offered for sale and distributed to consumers in the United States without marketing appr	Class IDevices	Dec 22, 2021
ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60Class IDec 22, 2021COVID test kits were offered for sale and distributed to con	COVID test kits were offered for sale and distributed to consumers in the United States without marketing appr	Class IDevices	Dec 22, 2021