Events

Retiro De Equipo (Recall) de Roche Cepheid LightCycler VZV Quality Kit

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Cepheid AB.

¿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
    17438
  • Fecha de inicio del evento
    2014-09-29
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Roche Diagnostics (NZ) Ltd, 15 Rakino Way, Mt Wellington, AUCKLAND 1644
  • Causa
    Users are requested to discontinue the use and discard any remaining inventory of specific lots of the lightcycler® vzv qual kit, ce-ivd which, due to kit stability issues, can lead to invalid results. due to the stability issues, positive control (pc) and non-template control (ntc) failures may be generated. previously generated, valid results do not need to be questioned or repeated.
  • Acción
    Product to be destroyed

Device

Roche Cepheid LightCycler VZV Quality Kit
  • Modelo / Serial
    Model: GMMI 04846788001, Affected: Lots: 70012381, 70012383, and 70012389
  • Manufacturer
    Cepheid AB

Manufacturer

Cepheid AB