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Empowered Diagnostics LLC recalls CovClear COVID-19 Rapid Antigen Test, ATG 900-031
Recalled February 9, 2022 · FDA recall Z-0480-2022 · 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
284,575 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
CovClear COVID-19 Rapid Antigen Test, ATG 900-031
Manufacturer(s)
Empowered Diagnostics LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →