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Completed

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

FDA Recall Z-0480-2022 · Posted None

Recalling FirmEmpowered Diagnostics LLC
Recall StatusCompleted
Product CodeQKP
Date Initiated2021-12-22
Product Quantity284,575 units

Reason for Recall

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

Firm Action

The firm notified their direct consignees by letter delivered by email on December 22, 2021. The letter explained the hazard and requested the discontinuation of use and distribution. Those who has further distributed the products, were requested to conduct a sub-recall.

Root Cause

No Marketing Application

Distribution Pattern

US Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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