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Empowered Diagnostics LLC recalls ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60
Recalled February 9, 2022 · FDA recall Z-0481-2022 · Empowered Diagnostics
Hazard
COVID test kits were offered for sale and distributed to consumers in the United States without marketing approval, clearance, or authorization from FDA. · FDA Class I
Units
2100 units
Sold at
US Nationwide Distribution
Description
COVID test kits were offered for sale and distributed to consumers in the United States without marketing approval, clearance, or authorization from FDA.
Product
ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60
Manufacturer(s)
Empowered Diagnostics LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →