FDA Recalls COVID-19 Antibody Test Kits for Lacking Regulatory Authorization
Lusys Laboratories is recalling 33,955 COVID-19 antibody test kits distributed across the US and internationally because the product lacks FDA authorization, clearance, or approval for marketing or use.
- Product
- COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies Catalog No: I-111
- Category
- Medical Device
- Distribution
- Distributed nationwide