Events

Retiro De Equipo (Recall) de cobas p 612 pre-analytical system (LCP1). 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
    Recall
  • ID del evento
    RC-2018-RN-00945-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-07-09
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00945-1
  • 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
    During internal investigations, roche diagnostics confirmed that in rare cases, sample material may come in contact with the pipetting nozzle during operation of the cobas p 612 pre-analytical system. this may lead to contamination of samples and, if a highly sensitive analytical technology is used e.G. molecular testing, inaccurate results may be produced.Cobas p 612 pre-analytical systems that use disposable filter tips are not affected by this issue.Roche has received no complaints worldwide for this issue; none from australian customers to date.
  • Acción
    Roche Diagnostics Australia is advising that the use of disposable filter tips in the cobas p 612 pre-analytical system will be mandatory until the root cause is identified and appropriate corrective actions have been implemented. Roche Diagnostics Australia will contact laboratories in due course to arrange the modifications required for using disposable filter tips. The root cause investigation is still ongoing. Roche will send an update as soon as the root cause is identified and corrective measures are available.

Device

cobas p 612 pre-analytical system (LCP1). An in vitro diagnostic medical device (IVD).
  • Modelo / Serial
    cobas p 612 pre-analytical system (LCP1). An in vitro diagnostic medical device (IVD).Affected part: ADP NozzleMaterial Number: 07563116001ARTG Number: 212706(Roche Diagnostics Australia Pty Limited - Instrument/analyser IVDs)
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited