Z-0833-2013 Class II Terminated

VENTANA (a member of the Roche Group) BenchMark ULTRA; REF/MU 750-600; Research Use Only Product Usage: Research Use Only-The DISCOVERY ULTRA Advanced Staining System is intended to automatically stain histological or cytological specimens on microscope slides with specific inununohistochemistry or in situ hybridization reagents.

Potiential for a waste fluid overflow condition to accur while running decontamination cycles on the BenchMark ULTRA automated staining platform or the DISCOVERY ULTRA automated staining platform. This type of overflow event can lead to migration of fluid across tubing and wiring within the instrument cabinet resulting in contact with electrical circuitry. This may create shorting conditions and u

Cat#750-600; PN 05342716001; Serial #'s: 310724, 310735, 311187, 312055, 310373, 311052, 311171, 311953, 310750, 311266, 311267, 311564, 311565, 311596, 311304, 310481, 311924, 310607, 311627, 310527, 311436, 311742, 310132, 311432, 310034, 310408, 310687, 310697, 311343, 311958, 310728, 310778, 311991, 312070, 310471, 311326, 311952, 310103, 310777, 311446, 310924, 311303, 311528, 310490, 310913, 311529, 311494, 310139, 310281, 310465, 310275, 310617, 310665, 310716, 311853, 311871, 312137, 312101, 310240, 310237,310238, 311571, 311404, 310356, 310023, 312164, 312165, 310065, 310231, 310711, 310706, 310707, 310703, 311509, 310330, 310633, 311811, 311810, 310977, 311194, 311198, 310208, 310732, 310740, 310187, 311462, 311935, 310145, 311037, 310346, 310585, 310694, 310699, 310701, 310702, 310705, 310709, 310710, 310704, 311106, 311110, 311111, 311419, 311484, 311527, 310345, 311381, 311353, 310480, 311869, 311921, 311458, 310315, 310412, 311988, 310618, 310397, 310399, 311868, 311919, 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310918, 310919, 312007, 310156, 310819, 311765, 311490, 311351, 311063, 310899, 310903, 311022, 311025, 311088, 310660, 311274, 312146, 310027, 310909, 311922, 310134, 310041, 310232, 310613, 311497, 312062, 311575, 311740, 311970, 310538, 310644, 310873, 311822, 311536, 311980, 310188, 310574, 311383, 310925, 310958, 310960, 311030, 311019, 311179, 311180, 310121, 311087, 310877, 310449, 310450, 310487, 311515, 311427, 311516, 311452, 310219, 310239, 312203 All serial numbers in the market