Events

Retiro De Equipo (Recall) de Device Recall EVOLIS Microplate System

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 Bio-Rad Laboratories, 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
    73030
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0807-2016
  • Fecha de inicio del evento
    2015-12-22
  • Fecha de publicación del evento
    2016-02-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142855
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Causa
    The error "washer reagent clean fluid" level low alarmed, which prompted the customer to open the system drawer. when the system drawer was opened the customer noted the plate transport was still running and as a consequence the plate was pushed off the plate transporter.
  • Acción
    Bio-Rad sent an Urgent Product Notification letter, dated December 22, 2015, to consignees via Fed-Ex. The firm recognized the typographical error of the PN number on the first letter and sent a revised notification letter, dated 20 January 2016, with the correct PN 89788 to consignees. The letter identified the affected product, problem and actions to be taken. Consignees are advised that in addition to the WARNING in Chapter 4.9.2 in the EVOLIS Operators Manual (PN 89788) mention is made of, "LED lamps on the front panel of the EVOLIS instrument illuminate when a compartment may be accessed. If an error occurs, (for example a bulk reagent becomes depleted) the system displays an error message, pauses, and allows access to the instrument compartments." The plate transport may still be moving the microplate to its final destination when access is allowed. To enhance safety features, your Field Safety Engineer (FSE) will apply a (yellow) warning label to the lower front panel. Labels are currently on order and once received will be provided to each FSE. The label will state: WARNING! Before opening instrument, ensure all moving parts have stopped". Consignees can contact Bio-Rad Technical Support directly at 1-800-224-6723, option #2, and then option #3 or by fax at 425-498-1628.

Device

Device Recall EVOLIS Microplate System
  • Modelo / Serial
    The EVOLIS Microplate System instrument is not lot controlled, however for traceability purposes each instrument is assigned a unique serial number.  SERIAL NUMBERS:  9163700126, 9163700175, 9163700187, 9163700196, 9163700208, 9163700210, 9163700231, 9163700266, 9163700278, 9163700320, 9163700328, 9163700336, 9163700337, 9163700349, 9163700354, 9163700368, 9163700402, 9163700431, 9163700449, 9163700478, 9163700480, 9163700481, 9163700495, 9163700498, 9163700499, 9163700501, 9163700510, 9163700527, 9163700530, 9163700531, 9163700544, 9163700556, 9163700558, 9163700559, 9163700560, 9163700567, 9163700585, 9163700587, 9163700594, 9163700595, 9163700623, 9163700624, 9163700625, 9163700629, 9163700656, 9163700695, 9163700696, 9163700722, 9163700743, 9163700744, 9163700745, 9163700764, 9163700765, 9163700772, 9163700775, 9163700776, 9163700810, 9163700821, 9163700822, 9163700823, 9163700835, 9163700836, 9163700843, 9163700844, 9163700846, 9163700850, 9163700851, 9163700853, 9163700855, 9163700857, 9163700862, 9163700863, 9163700864, 9163700868, 9163700873, 9163700874, 9163700875, 9163700877, 9163700879, 9163700883, 9163700884, 9163700885, 9163700887, 9163700888, 9163700889, 9163700890, 9163700891, 9163700892, 9163700893, 9163700895, 9163700898, 9163700899, 9163700901, 9163700902, 9163700906, 9163700907, 9163700909, 9163700910, 9163700911, 9163700912, 9163700913, 9163700914, 9163700916, 9163700917, 9163700918, 9163700919, 9163700920, 9163700921, 9163700922, 9163700926, 9163700927, 9163700928, 9163700929, 9163700930, 9163700931, 9163700932, 9163700933, 9163700934, 9163700935, 9163700936, 9163700937, 9163700938, 9163700939, 9163700941, 9163700942, 9163700943, 9163700945, 9163700946, 9163700947, 9163700948, 9163700949, 9163700950, 9163700952, 9163700956, 9163700957, 9163700959, 9163700960, 9163700961, 9163700962, 9163700964, 9163700965, 9163700966, 9163700967, 9163700968, 9163700972, 9163700973, 9163700974, 9163700975, 9163700977, 9163700978, 9163700979, 9163700980, 9163700981, 9163700982, 9163700984, 9163700985, 9163700987, 9163700988, 9163700989, 9163700991, 9163700992, 9163700993, 9163700996, 9163700997, 9163700998, 9163700999, 9163701000, 9163701001, 9163701002, 9163701003, 9163701004, 9163701005, 9163701006, 9163701007, 9163701008, 9163701009, 9163701010, 9163701011, 9163701012, 9163701013, 9163701014, 9163701015, 9163701017, 9163701018, 9163701019, 9163701020, 9163701021, 9163701022, 9163701023, 9163701024, 9163701025, 9163701026, 9163701027, 9163701028, 9163701029, 9163701030, 9163701031, 9163701032, 9163701033, 9163701034, 9163701035, 9163701036, 9163701037, 9163701038, 9163701039, 9163701040, 9163701041, 9163701042, 9163701043, 9163701044, 9163701045, 9163701046, 9163701047, 9163701048, 9163701049, 9163701051, 9163701052, 9163701053, 9163701054, 9163701056, 9163701057, 9163701058, 9163701059, 9163701060, 9163701061, 9163701063, 9163700168R, 9163700172R, 9163700176R, 9163700202R, 9163700206R, 9163700209R, 9163700215R, 9163700221R, 9163700234R, 9163700236R, 9163700242R, 9163700246R, 9163700247R, 9163700276R, 9163700281R, 9163700282R, 9163700293R, 9163700294R, 9163700296R, 9163700326R, 9163700327R, 9163700330R, 9163700355R, 9163700359R, 9163700397R, 9163700398R, 9163700400R, 9163700432R, 9163700479R, 9163700494R, 9163700562R, 9163700563R, 9163700564R, 9163700565R, 9163700573R, 9163700617R, 9163700811R, 9163700834R, 9163700837R, 9163700878R, 9163700881R, 9163700886R, 9163700904R, 9163700908R, 9163700915R, 9163700925R, 9163700951R, 9163700958R, 9163700969R, 9163700971R, 9163700986R, and 916370726R.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution including Puerto Rico.
  • Descripción del producto
    EVOLIS Microplate System, Catalog # 89601. Part number 89788 for the EVOLIS Operator's Manual. in vitro diagnostic || Product Usage: || EVOLIS Microplate System is a 4 plate fully integrated microplate processing system designed for use with multiple EIA assays.
  • Manufacturer
    Bio-Rad Laboratories, Inc.

Manufacturer

Bio-Rad Laboratories, Inc.
  • Dirección del fabricante
    Bio-Rad Laboratories, Inc., 6565 185th Ave NE, Redmond WA 98052-5039
  • Empresa matriz del fabricante (2017)
    Bio-Rad Laboratories Inc
  • Source
    USFDA