Ovulation test devices recalled over missing FDA premarket clearance
Changchun Wancheng Bio-Electron is recalling 1,000 units of the LH One Step Ovulation Test Device (Urine) because tests requiring a 510(k) were distributed before they could be legally marketed.
- Product
- LH One Step Ovulation Test Device (Urine)
- Category
- Medical Device
- Distribution
- Distributed nationwide