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.

Class I - Dangerous

🏥 Medical Devices Recalled: September 28, 2012 Ventana Medical Systems Other Medical Devices Nationwide

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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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310410, 312088, 311407, 310043, 310044, 310045, 310818, 310085, 311120, 311918, 311989, 311117, 310179, 311105, 311049, 312176, 310099, 311563, 310100, 310190, 311823, 310058, 310061, 310864, 311389, 310805, 310048, 311911, 311425, 311146, 310228, 310260, 311534, 310736, 310738, 310722, 311223, 310128, 310137, 310059, 312140, 311471, 311519, 310831, 310120, 311307, 310806, 311902, 310319, 311798, 311802, 312129, 312130, 311076, 311139, 311132, 311181, 311496, 311507, 312147, 312154, 310762, 310447, 311168, 310466, 311619, 311617, 310451, 311415, 311756, 312048, 311149, 310892, 311488, 311491, 311238, 311531, 311801, 311898, 311934, 310101, 310142, 311532, 311317, 311341, 310637, 311310, 311237, 310880, 311420, 312053, 311940, 311941, 311951, 311467, 310209, 310817, 311708, 310413, 311755, 310462, 310464, 311927, 311697, 310354, 312057, 311041, 311115, 311492, 311441, 310195, 310125, 310194, 310223, 310222, 310279, 310469, 310795, 310326, 311502, 311192, 311039, 311051, 311385, 310405, 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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
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Ventana Medical Systems Inc
Reason for Recall:: 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
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

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.

Product Codes/Lot Numbers:

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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311764, 310850, 311413, 310825, 310743, 310744, 310785, 310801, 310802, 310280, 310303, 311251, 311406, 311200, 311333, 310401, 311271, 310325, 311920, 310793, 310684, 310068, 311262, 311264, 310109, 311161, 311487, 312119, 311834, 311950, 311729, 311437, 311444, 312054, 311053, 311046, 311193, 310649, 310392, 311860, 310409, 312120, 312121, 311104, 311892, 310812, 310996, 310556, 311936, 310739, 311677, 312064, 312065, 312110, 312113, 310883, 311907, 311945, 310639, 311900, 310564, 311522, 311535, 311239, 311240, 310809, 311296, 311843, 311454, 311480, 310476, 312095, 311997, 311820, 310566, 311784, 311258, 310192, 310758, 311818, 311899, 311201, 311382, 310843, 310733, 310734, 311712, 311440, 311150, 310937, 310737, 310680, 310829, 311430, 310609, 310741, 311246, 311253, 311342, 310545, 310568, 311699, 311698, 310939, 310942, 310496, 310907, 311909, 310692, 310926, 310534, 311269, 310838, 310327, 311852, 312111, 310891, 310062, 310172, 310834, 310463, 310502, 310914, 311944, 311021, 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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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0833-2013

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