FDA (Devices) recall action 89315
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
COVID test kits were offered for sale and distributed to consumers in the United States without marketing approval, clearance, or authorization from FDA.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
CovClear COVID-19 Rapid Antigen Test kits (284,575 units) were distributed nationwide without FDA marketing approval, clearance, or authorization. All lots are recalled.
Empowered Diagnostics LLC recalled COVID-19 test kits (ImmunoPass, NAB 900-60) sold nationwide without FDA approval. Approximately 2,100 units were distributed without required marketing clearance or authorization.