FDA recall Z-0480-2022

Empowered Diagnostics LLC · Class I · device

Product

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

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.

Distribution

US Nationwide Distribution

Key facts

Status: Completed
Initiation date: 2021-12-22
Report date: 2022-02-09
Voluntary/Mandated: Voluntary: Firm initiated
Location: Pompano Beach, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0480-2022