Retiro De Equipo (Recall) de cobas e 411 analyser. An in vitro diagnostic medical device (IVD)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Roche Diagnostics Australia Pty Limited.

¿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 II
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    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, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    Roche diagnostics have identified that in very rare cases, a software malfunction in the “sample & control” data file may occur, which could lead to a potential sample mismatch (incorrect test order and incorrect result reporting). the impact of any data mismatch cannot be predicted. the system may still be used routinely as long as the workaround and corrective actions are taken into account. this software malfunction can only occur:- when the “sample data clear” function is not performed routinely as indicated in the operator’s manual; and- when the “sample & control” datafile of the cobas e 411 analyser is filled with = 2,000 records.All tests run on the cobas e 411 analyser are potentially affected if these criteria are met. the extent of the bias cannot be predicted and the detectability of this issue is not certain. a relevant medical risk cannot be entirely excluded.A small number of complaints have been received, however none from australian customers, to date.
  • Acción
    Roche Diagnostics is requesting that customers adhere to the following: 1. Until the software update has been installed, it is MANDATORY to perform a “Sample Data Clear” daily: “Sample Data Clear” is step no. 2 in the Work Flow Guide in the System Overview window. Please note: A Sample Data Clear deletes all sample records and moves QC data to the QC view. It is recommended to perform the backup procedure on a regular basis, depending on the data volume at the laboratory site. If the system is connected to a host, ensure that all data has been uploaded before performing a sample data clear. 2. Follow the instructions given in the customer letter supplied and then display it in a prominent place in the laboratory until the mandatory software upgrade has been installed.


  • Modelo / Serial
    cobas e 411 analyser. An in vitro diagnostic medical device (IVD)cobas e 411 analyser (disk system)Material Number: 04775279001cobas e 411 analyser (rack system)Material Number: 04775201001All Software versionsARTG Number: 173887
  • Manufacturer