Recall Z-1549-2013— Aperio Technologies Inc
Class II · Terminated
Class II FDA medical device recall by Aperio Technologies Inc, initiated 2013-02-22, terminated 2013-09-25. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Aperio initiated this recall because the User Guides incorrectly state the devices had been cleared for specific applications. The User Guides should state the devices are for Research Use Only and are not for use in diagnostic procedures..
- Recalling firm
- Aperio Technologies Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-02-22
- Terminated
- 2013-09-25
- Firm location
- Vista, CA, United States
Product description
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.
Reason for recall
Aperio initiated this recall because the User Guides incorrectly state the devices had been cleared for specific applications. The User Guides should state the devices are for Research Use Only and are not for use in diagnostic procedures.
Data sourced from openFDA. This site is unofficial and independent of the FDA.