PhenoMATRIX bacterial culture plate interpretation software recalled nationwide
Copan WASP is recalling PhenoMATRIX, an AI-powered bacterial culture plate interpretation software, because it lacks required FDA premarket approval, creating potential risk of inaccurate colony counts and morphology data that could affect patient diagnosis.
- Product
- PhenoMATRIX
- Category
- Medical Device
- Distribution
- Distributed nationwide