Recall Z-0481-2022 ยท QKO Reagent, Coronavirus Serological
Empowered Diagnostics LLC
ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60
| 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 | 2100 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.