Vivoo sodium and hydration tests recalled over missing premarket clearance
Changchun Wancheng Bio-Electron is recalling 3,300 units of Vivoo Sodium Test because tests requiring a 510(k) were distributed before they could be legally marketed.
- Product
- Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test
- Category
- Medical Device
- Distribution
- Distributed nationwide