Events

Retiro De Equipo (Recall) de BenchMark ULTRA

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Ventana Medical Systems Inc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    64244
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0833-2013
  • Fecha de publicación del evento
    2013-08-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-02-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115665
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Slide stainer, automated - Product Code KPA
  • Causa
    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.
  • Acción
    The firm, Roche sent a "Technical Bulletin" and an letter dated October 3, 2012 to its customers. The letter and bulletin described the product, problem and actions to be taken. The customers were informed that Ventana is aggressively working on solutions to this issue. Until mitigations to the overflow condition are available for implementation; inform all personnel in your organization that work with the BenchMark ULTRA or DISCOVERY ULTRA instrument about the potential for fluid overflow to occur during decontamination cycles; follow the instructions provided in the letter to avoid the documented failure mode and follow the instructions provided in the technical bulletin. Contact your local support center with any questions or concerns or call 520-877-7191.

Device

BenchMark ULTRA
  • Modelo / Serial
    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, 312139, 312141, 312142, 311270, 310069, 311466, 311929, 310083, 310094, 310154, 311904, 310588, 312098, 312100, 310814, 311731, 311783, 311785, 312096, 312104, 312153, 310227, 310781, 310174, 311403, 311080, 311081, 311121, 311122, 311169, 311188, 311189, 311190, 311242, 311245, 311298, 311926, 310403, 310718, 311416, 311417, 312105, 312112, 310796, 310832, 310824, 311135, 311248, 312066, 310895, 310267, 310272, 311481, 311771, 311772, 310882, 311186, 311937, 310344, 311439, 311505, 310146, 310506, 311545, 310446, 310312, 311584, 312124, 310839, 311319, 311261, 310070, 310508, 311367, 311578, 311576, 311629, 311601, 311600, 311607, 311603, 311602, 311606, 311598, 311597, 311604, 311605, 311599, 311272, 312145, 312123, 310339, 310455, 310472, 310478, 310482, 311562, 311560, 311923, 311498, 311814, 311813, 311804, 310020, 310844, 311313, 311533, 310779, 311241, 311750, 310268, 310331, 311221, 311036, 311034, 311035, 310201, 310321, 310792, 312056, 311147, 311153, 311315, 311308, 310641, 310678, 310878, 310032, 311774, 311182, 310390, 311151, 311268, 311284, 311552, 310902, 311455, 310491, 311038, 312008, 310282, 310696, 311735, 310173, 310402, 311710, 312118, 311874, 310972, 311375, 311727, 312128, 312134, 310933,  310921, 311285, 310297, 310769, 311876, 310916, 311486, 310460, 310245, 310576, 311483, 312097, 312099, 312089, 312109, 311518, 311479, 311901, 312144, 312172, 311551, 310555, 310363, 311808, 310570, 311001, 310358, 310492, 311252, 311687, 311672, 311402, 310114, 310122, 310126, 311300, 310794, 311350, 311592, 310749, 310285, 311299, 310897, 311323, 310258, 310467, 310470, 311628, 310943, 310035, 310066, 310087, 310185, 310752, 310757, 311134, 312138, 310489, 311973, 311191, 310456, 310575, 310673, 310683, 310890, 310821, 312170, 312171, 312060, 312102, 312202, 310500, 310505, 311394, 311917, 311511, 311530, 310894, 312136, 311369, 311665, 312152, 310804, 311517, 311465, 310893, 310896, 311946, 311947, 310323, 310776, 310654, 310299, 310452, 311675, 310404, 310810, 310708, 310712, 311073, 311250, 310910, 311401, 311928, 310941, 310026, 310089, 310336, 310341, 311736, 311610, 311608, 311609, 311728, 310820, 311821, 310141, 310912, 311443, 311442, 311243, 311207, 310256, 310378, 310229, 312163, 312058, 310771, 311103, 310915, 310533, 310124, 311318, 310218, 310811, 311738, 310037, 310038, 310365, 310377, 311210, 312085, 312086, 312087, 311295, 312023, 311493, 311357, 310833, 310800, 311464, 311423, 311173, 311364, 310135, 310608, 310935, 311352, 311354, 311356, 310920, 310183, 310257, 310306, 310852, 311431, 310876, 311949, 311956, 310828, 310830, 310928, 310929, 310930, 310355, 310271, 311384, 312122, 310846, 311345, 310119, 310391, 310881, 310483, 310488, 311893, 312063, 310284, 311663, 312131, 310374, 310507, 310144, 310775, 311730, 311939, 310106, 310205, 310241, 310620, 310713, 310031, 310742, 311016, 311463, 310445, 312117, 310906, 311376, 311377, 311378, 311379, 311380, 310288, 311334, 311957, 311714, 310898, 311477, 310210, 310224, 311033, 312076, 312078, 312090, 310632, 312116, 310751, 310249, 311468, 310923, 310123, 311760, 310180, 311160, 310905, 310605, 310458, 311925, 310822, 311485, 311503, 311500, 311474, 310879, 312061, 310189, 310191, 312039, 312051, 312052, 312059, 312188, 311948, 311072, 310182, 310503, 310922, 311172, 311461, 311324, 311209, 310799, 310807, 310314, 310855, 312127, 310084, 310165, 311322, 311321, 310573, 310572, 311559, 310375, 310181, 310308, 312103, 312077, 312106, 312107, 312108, 310474, 310486, 312021, 312167, 312169, 311247, 310634, 310461, 312203, 310730, 310729, 311065, 311348, 311346, 311332, 310763, 312126, 310036, 310348, 310362, 311395, 311459, 311472, 311236, 311450, 311451, 310884, 311118, 311887, 311337, 311338, 310842, 310028, 310318, 310479, 311773, 311259, 311679, 312009, 312012, 310283, 310453, 310501, 310663, 310889, 310715, 311482, 311183, 311184, 310610, 311520, 311506, 310369, 310770, 310351, 310827, 310497, 311006, 311399, 311040, 311355, 312132, 312133, 311510, 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, 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, 310316, 311695, 311703, 311805, 311806, 311807, 311809, 312003,311005, 310885, 311752, 311751, 311732, 312150, 311942, 312026, 310676, 310225, 310353, 310473, 310475, 311508, 310717, 311089, 311148, 311138, 311140, 311141, 311320, 310454, 312143, 310593, 310591, 310657, 312081, 312125, 310226, 310611, 311349, 312151, 310322, 310064, 310748, 310216, 310494, 310495, 311029, 310217, 312016, 311775, 311777, 310443, 310597, 310603, 310602, 310606, 310360, 310130, 310131, 310133, 310143, 311178, 310138, 310140, 310276, 311792, 311504, 311501, 311499, 310411, 310621, 310690, 310727, 311249, 311288, 311400, 311418, 311457, 311470, 311696, 311694, 311693, 311309, 310040, 310681, 310823, 310798, 311056, 310416, 311408, 311344, 311906, 311624, 312017, 312033, 311943, 311048, 311409, 311495, 311758, 311093, 311447, 311885, 310367, 311489, 310352, 311975, 311977, 311339, 310376, 310379, 311653, 311199, 310385, 310414, 310485, 311260, 310244, 311365, 311366, 310324, 310033, 310304, 312010, 312011, 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
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) and country of: Germany.
  • Descripción del producto
    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.
  • Manufacturer
    Ventana Medical Systems Inc

Manufacturer

Ventana Medical Systems Inc
  • Dirección del fabricante
    Ventana Medical Systems Inc, 1910 E Innovation Park Dr, Oro Valley AZ 85755-1962
  • Empresa matriz del fabricante (2017)
    Roche Holding Ag
  • Source
    USFDA