Recall Z-0480-2022 ยท QKP Coronavirus Antigen Detection Test System.
Empowered Diagnostics LLC
CovClear COVID-19 Rapid Antigen Test, ATG 900-031
| Date | Dec 22, 2021 |
| Status | Completed |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.