Home male fertility tests recalled over missing FDA premarket clearance
Changchun Wancheng Bio-Electron is recalling 1,000 units covering the Male Fertility Sperm Test for Home Use (Cassette) because tests requiring a 510(k) were distributed before they could be legally marketed.
- Product
- Male Fertility Sperm Test for Home Use (Cassette)
- Category
- Medical Device
- Distribution
- Distributed nationwide