Events

Retiro De Equipo (Recall) de Device Recall cobas e 411 Immunoassay 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 Corporation.

¿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
    78756
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0498-2018
  • Fecha de inicio del evento
    2017-07-05
  • Estado del evento
    Open, Classified
  • 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=160288
  • 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
    A software malfunction can occur on the cobas e 411 and elecsys 2010 analyzers in the sample& control data file which may lead to a potential data mismatch.
  • Acción
    All consignees were notified by Urgent Medical Device Correction sent via UPS Ground (receipt required) on July 5, 2017. The customer is advised to perform the following actions: cobas e 411: Until the software update is available, use the workaround outlined in the Urgent Medical Device Correction (UMDC). Elecsys 2010: Use the workaround outlined in this Urgent Medical Device Correction (UMDC). Non-responding accounts will be defined as users for which confirmation of receipt of the Urgent Medical Device Correction (UMDC) cannot be obtained. These accounts will be monitored on an ongoing basis and follow-up attempts will be made accordingly. Workaround for customers: he customer is advised to perform the following actions: cobas e 411: Until the software update is available, use the workaround outlined in the Urgent Medical Device Correction (UMDC). Elecsys 2010: Use the workaround outlined in this Urgent Medical Device Correction (UMDC). For further questions, please call (317) 521-7259

Device

Device Recall cobas e 411 Immunoassay Analyzer
  • Modelo / Serial
    none
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    cobas e 411 Immunoassay Analyzer-Model/Catalog/Part number: 04775279001/04775279973 - cobas e 411 analyzer (disk system) and 04775201001/04775201973 - cobas e 411 analyzer (rack system), medial device listing number: E116019 cobas e 411 || Elecsys analyzer is a fully automated, random access, computer controlled analytical systems for quantitative and qualitative determinations of analytes in body fluids.
  • Manufacturer
    Roche Diagnostics Corporation

Manufacturer

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