FDA-Device2013-06-26Class II
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.
Aperio Technologies Inc
Hazard
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.
Sold states
Nationwide Distribution - including all states, none internationally .
Affected count
364
Manufactured in
1360 Park Center DR, Vista, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1549-2013Don't want to check this manually?
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