FDA Recalls Unauthorized E25Bio COVID-19 Diagnostic Test Kit
E25Bio COVID-19 diagnostic tests have been recalled following nationwide distribution without FDA authorization or approval. The distributed units lacked sufficient directions and quality controls needed for safe diagnostic use.
- Product
- E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit
- Category
- Medical Device
- Distribution
- Distributed nationwide