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FDADecember 22, 2021device

CovClear COVID-19 Rapid Antigen Test, ATG 900-031

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

COVID test kits were offered for sale and distributed to consumers in the United States without marketing approval, clearance, or authorization from FDA.

What to do

FDA enforcement status: Completed

Brands named

empowered diagnosticsempowered

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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CovClear COVID-19 Rapid Antigen Test, ATG 900-031 — Recall Details · AllClear