Aperio ScanScope Systems Recalled for Incorrect User Guide Labeling
Aperio Technologies is recalling 364 ScanScope systems because user guides incorrectly claim FDA clearance for diagnostic use, when the devices are for research only.
- Product
- Aperio ScanScope System. Aperio ScanScope Models, XT, AT, AT Turbo, CS and CSO. Automated digital slide creation and viewing device. It is intended to create and view electronic image files representative of tissue specimens fixed to glass slides.
- Category
- Medical Device
- Distribution
- Distributed nationwide