Retiro De Equipo (Recall) de Device Recall Cobas c8000 Modular Analyzer Series Cobasc502

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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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 initial cassette volume check (icvc) is not activated on the cobas c 502 module of the cobas 8000 modular analyzer series when manually filled cobas c packs are loaded. this issue occurs with tests that use cobas c pack multi or empty pre-labeled cobas c packs. the icvc feature allows the reagent probe to dive into the reagent cassette and confirm the reagent level in the bottles. this ensures.
  • Acción
    March 17, 2014 all consignees will be notified by Urgent Medical Device Correction sent via UPS Ground (receipt required). The notice identified the issue, root cause, affected assays with clinical significance. Consignees were instructed to follow the steps listed in the Urgent Medical Device Correction to correctly activate the ICVC and verify the correction. If your system is not connected to the Internet through the cobas link, and you do not have the option to run the affected reagents on an alternate system (i.e., cobas c 311 or cobas c 501 analyzer), please contact the Roche Support Network Customer Support Center at 1-800-428-2336 to have an update scheduled via a Roche Field Representative. If your system is connected to the Internet through the cobas link, follow the steps below: " Remove all reagent cobas c packs on board your cobas c 502 module for the assays listed on pages 1-2. " Dispose of these reagent cobas c packs according to your local waste management ordinances. " Load new cobas c packs for the affected assays, and visually verify the ICVC is performed. " Complete the attached fax form (5326-00-0314) and fax it to 1-888-276-6166. " Please consult with the physician or pathologist at your facility to determine specific clinical implications for your patients. " File this Urgent Medical Device Correction (UMDC) for future reference.


  • Modelo / Serial
    not applicable
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    USA Nationwide Distribution including San Juan PR
  • Descripción del producto
    Cobas c8000 Modular Analyzer Series Cobas c502, Part Number 5964067001, a clinical chemistry analyzer intended for the in vitro quantitative / qualitative determination of analytes in body fluids.
  • Manufacturer


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