Z-0481-2022 Class I
FDA device recall Z-0481-2022 was initiated by Empowered Diagnostics LLC on December 22, 2021 and is designated Class I. 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. Affected quantity: 2100 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 9, 2022
- Initiation Date
- December 22, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2100 units
Product Description
ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60
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.
Distribution Pattern
US Nationwide Distribution
Code Information
all lots