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Aperio Technologies Inc recalls Aperio ScanScope System. Aperio ScanScope Models, XT, AT, AT Turbo, CS and CSO. Automated digital slide creation and vi
Recalled June 26, 2013 · FDA recall Z-1549-2013 · Aperio Technologies
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. · FDA Class II
Units
364
Sold at
Nationwide Distribution - including all states, none internationally .
Description
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.
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.
Manufacturer(s)
Aperio Technologies Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →