Exploro fertility tests recalled over missing FDA premarket clearance
Changchun Wancheng Bio-Electron is recalling 4,800 units of the Exploro Highly Sensitive Male Fertility / Sperm Concentration Test because tests requiring a 510(k) were distributed before they could be legally marketed.
- Product
- Exploro Highly Sensitive Male Fertility / Sperm Concentration Test
- Category
- Medical Device
- Distribution
- Distributed nationwide