Recall Z-0481-2022
Empowered Diagnostics LLC · initiated December 22, 2021
Class I – dangerous or defective products that could cause serious health problems or death
Product
ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60
Codes / lots: all lots
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.
FDA-determined cause: No Marketing Application
Action taken
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.
Details
- Recall number
- Z-0481-2022
- Initiated
- December 22, 2021
- Product code
- QKO – Reagent, Coronavirus Serological
- Quantity
- 2100 units
- Distribution
- US Nationwide Distribution
- Recalling firm
- Empowered Diagnostics LLC, Pompano Beach, FL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0480-2022 Class I | CovClear COVID-19 Rapid Antigen Test, ATG 900-031COVID test kits were offered for sale and distributed to consumers in the United States without marketing… | 12/22/2021Completed |