Empowered Diagnostics LLC: Medical Device Recall in 2022 - (Recall #: Z-0480-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: December 22, 2021

Date Posted: February 9, 2022

Recall Number: Z-0480-2022

Event ID: 89315

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.

Status: Completed

Product Quantity: 284,575 units

Code Information:

All lots

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated