First Response Easy Read App unable to reliably read pregnancy test results
Church & Dwight's Easy Read App for pregnancy test sticks may fail to display test results or misread them, leading to false positive or false negative results. The app was marketed without required FDA clearance.
- Product
- Easy Read App associated with First Response Pregnancy Test Sticks - Intended use of converting analog pregnancy test results into text pregnant or not pregnant for display on consumer devices (e.g., smart phone, iPad)
- Category
- Medical Device
- Distribution
- Distributed nationwide