Events

Retiro De Equipo (Recall) de Device Recall Omni Microelectrode for cobas b221 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
    67549
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1315-2014
  • Fecha de inicio del evento
    2014-02-28
  • Fecha de publicación del evento
    2014-04-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125702
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Notas adicionales en la data
  • Causa
    Reference electrode used beyond the guaranteed in-use 52 week lifetime,may leak and potentially cause erroneous ph and/or sodium results. other ion parameters are not affected.
  • Acción
    Roche Diagnostics Operations sent an Urgent Medical Device Correction letter dated February 27, 2014 via UPS Ground (receipt required) to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the enclosed fax form and fax it to 1-888-345-0253. For questions contact Roche Customer Business Support Center at 1-800-428-5076.

Device

Device Recall Omni Microelectrode for cobas b221 analyzer
  • Modelo / Serial
    all serial numbers
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Distribución
    Worldwide Distribution - USA nationwide including PR and the country of Guam.
  • Descripción del producto
    Omni Micro-electrode/reference electrode for cobas b221 analyzer, Model/Catalog/Part Number: || 03111873180 as a part of the following systems: || 1. 03337103001, cobas b 221<1>Roche OMNI S1 system || 2. 03337111001, cobas b 221<2>Roche OMNI S2 system || 3. 03337154001,cobas b 221<6>Roche OMNI S6 system || 4. 03337138001, cobas b 221<4>Roche OMNI S4 system || Product Usage: Usage: || Blood Gas and Electrolytes Analyzer c. Classification Name: Fully automated Critical Care Analyzer for the measurement of pH, Blood gases, electrolytes, Hematocrit, hemoglobin, glucose, lactate, urea/BUN, total hemoglobin, Oxygen saturation, oxy - deoxycarboxy and methemoglobin
  • Manufacturer
    Roche Diagnostics Operations, Inc.

Manufacturer

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