Events

Retiro De Equipo (Recall) de Cobas 4800 HPV Amplification/Detection Reagents, 240 tests and 960 tests240 tests

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-2013-RN-00752-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2013-07-23
  • 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-2013-RN-00752-1
  • 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 an internal investigation, a formulation error was identified during the manufacture of the cobas 4800 hpv master mix reagent leading to an increased rate of invalid runs. this issue does not cause incorrect specimen results, however results from failed runs must be repeated.
  • Acción
    Roche is requesting users to discontinue use and discard all units from the affected lots. Roche will replace any affected units.

Device

Cobas 4800 HPV Amplification/Detection Reagents, 240 tests and 960 tests240 tests
  • Modelo / Serial
    Cobas 4800 HPV Amplification/Detection Reagents, 240 tests and 960 tests240 testsPart Numbers: 05235901190Lot Numbers: R15771 960 testsPart Numbers: 05235910190Lot Numbers: R15304
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited