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