Events

Retiro De Equipo (Recall) de cobas c 311 Analyzer

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 Roche Diagnostics Operations, 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
    60282
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0310-2012
  • Fecha de inicio del evento
    2011-10-26
  • Fecha de publicación del evento
    2011-11-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-07-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104939
  • 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 cobas c 311 analyzer software may incorrectly calculate the volume of the ise reference electrolyte solution remaining on the analyzer. in some cases the incorrect results obtained will not be flagged with any data alarms.
  • Acción
    October 26, 2011 Urgent Medical Device Corrections were sent to all direct accounts in the USA that have installed the cobas c 311 analyzer and included a faxback form to be completed and faxed to 1-877-766-7452. Consignees were instructed to temporarily replace the ISE Reference Electrolyte bottle based upon the frequency calculated from the maximum number of ISE samples run per day and activate the yellow threshold alarm on the system. Customers with question and concerns are directed to call Roche Diagnostics Technical Support at 1-800-428-2366, available 24-hours, 7 days a week.

Device

cobas c 311 Analyzer
  • Modelo / Serial
    Serial Numbers:1050-16, 1040-08, 1041-06, 0927-16, 0918-05, 1048-02, 0812-12, 1058-09, 0925-20, 1044-19, 1041-05, 1043-15, 1056-18, 0812-09, 1038-07, 0814-10, 1041-19, 1170-04, 0929-08, 0919-16, 0814-03, 0926-11, 1035-01, 1034-19, 1035-10, 1174-19, 1176-03, 1067-02, 0919-17, 0920-05, 0927-13, 1060-17, 1060-05, 0927-17, 1044-18, 0812-10, 0811-20, 1041-20, 1174-04, 0925-05, 1060-01, 1062-09, 1066-20, 1174-07, 0814-15, 0814-17, 1053-16, 1054-02, 1034-02, 1052-16, 1052-19, 0918-06, 1052-13, 1052-20, 1052-15, 1034-07, 1043-10, 0811-15, 1054-03, 1061-08, 1043-06, 0926-10, 1044-06, 1034-03, 1052-09, 1043-12, 1055-01, 0929-09, 1038-05, 1034-01, 0810-19, 1054-20, 1062-07, 1059-20, 0814-16, 1043-14, 1062-08, 1054-01, 0929-07, 1038-06, 1056-19, 1057-03, 1169-20, 0926-19, 1067-01, 1038-04, 0925-06, 1043-08, 1043-13, 0812-11, 1057-05, 1060-06, 0926-16, and 1034-06.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA including the states of Maryland and Texas.
  • Descripción del producto
    cobas c 311 Analyzer, Part Number: 04826876001 || In-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or turbidimetrically; the analyzer also has an optional ISE module for measuring sodium, potassium and chloride.
  • Manufacturer
    Roche Diagnostics Operations, Inc.

Manufacturer

Roche Diagnostics Operations, Inc.
  • Dirección del fabricante
    Roche Diagnostics Operations, Inc., 9115 Hague Road, Indianapolis IN 46256-1025
  • Empresa matriz del fabricante (2017)
    Roche Holding AG
  • Source
    USFDA