FDA Medical Device Recalls (openFDA)
Empowered Diagnostics LLC: CovClear COVID-19 Rapid Antigen Test, ATG 900-031
- Recall number
- Z-0480-2022
- Recalling firm
- Empowered Diagnostics LLC
- Product
- CovClear COVID-19 Rapid Antigen Test, ATG 900-031
- Status
- Completed
- Initiated
- 2021-12-22
- Posted
- not on file
- Terminated
- not on file
- Reason
- COVID test kits were offered for sale and distributed to consumers in the United States without marketing approval, clearance, or authorization from FDA.
- Root cause
- No Marketing Application
- 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.
- Quantity
- 284,575 units
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- All lots
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QKP
- Firm FEI
- 3017977164
- Firm city
- Pompano Beach
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28