Events

Retiro De Equipo (Recall) de Roche Online Dat Cannabinoids II

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 manufacturer #1479.

¿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
    18231
  • Fecha de inicio del evento
    2015-04-09
  • 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
    Internal investigations by roche diagnostics verified that within the run precision (cv) for the positive/negative control with different reagent lots is approximately 10%. the specification is lower than 8%. patient sample results which are very close to the cutoff might recover below the cutoff. the affected reagent lots expire in may 2015., newer lots are not affected by the precision issue and can be used as a replacement.
  • Acción
    Product to be destroyed

Device

Roche Online Dat Cannabinoids II
  • Modelo / Serial
    Model: Catalogue Number: 04491009190, Affected: Lot numbers: 698113, 604195, 604194, 696131, 698110 & 696133
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479