Events

Retiro De Equipo (Recall) de cobas MPX test. 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-00356-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-05-14
  • 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-00356-1
  • 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
    Globally, roche has received a number of customer reports of selected lots of the cobas mpx test generating unexpected initial false reactive results, which do not match the serology profile of the sample. roche diagnostics australia has received no reports of false reactive results with the affected lot numbers from australian customers.
  • Acción
    Roche is requesting users to discontinue use of and discard any remaining inventory of the affected lots, on receipt of replacement unaffected stock. A Roche Diagnostics Australia representative will be in touch with any affected customers to arrange replacement stock.

Device

cobas MPX test. An in vitro diagnostic medical device (IVD).
  • Modelo / Serial
    cobas MPX test. An in vitro diagnostic medical device (IVD). Material Number: 06997708190 (96 tests)Lot Numbers: 242567 and 267989ARTG Number: 275469Roche Diagnostics Australia - cobas MPX. - HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited