Retiro De Equipo (Recall) de cobas 4800 HPV Amplification/Detection Kit. 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 III
  • 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
    Through routine quality stability monitoring, roche has been made aware that certain lots of the cobas 4800 hpv amplification/detection kit are generating an increase in the frequency of invalid positive control (pc) results, causing the entire run to be invalidated on the cobas 4800 system. as a precautionary measure, roche has additionally temporarily shortened expiration dates for other selected lots of these kits to reduce the potential for invalid pc result generation.
  • Acción
    Roche Diagnostics is requesting users with affected lots (as reflected in Table 1 of the recall notification) to immediately discontinue use of and discard the indicated lots. Users with affected lots (as reflected in Table 2) are advised to be aware of and adhere to the revised expiry date of the indicated lots. (Users are to note that the cobas 4800 System will not recognise nor flag the revised expiry of the affected kits. Therefore, close attention must be paid to the expiry dates listed in Table 2 and appropriate action taken accordingly.) Users will be assisted with the process of supply of replacement kits.


  • Modelo / Serial
    cobas 4800 HPV Amplification/Detection Kit. An in vitro diagnostic medical device (IVD)Material Numbers: 05235910190 and 05235901190Pack Size: 960 and 240 tests (respectively)Multiple Lot NumbersARTG Number: 187190
  • Manufacturer