Events

Retiro De Equipo (Recall) de Siemens ADVIA Chemistry Systems, Amylase

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 Siemens Healthcare Diagnostics Inc.

¿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
    18384
  • Fecha de inicio del evento
    2015-04-20
  • 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: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
  • Causa
    Siemens healthcare diagnostics has confirmed that amylase reagent kit lots 304821 and 304816 for use on the advia® 1200, 1650, 1800 and 2400 chemistry systems demonstrate an increased incidence of absorbance flags (u or u accompanied by u). absorbance flags (u) indicate an abnormally high reagent blank absorbance exceeding the reagent blank limit. in some cases with these reagent lots, sample results may also have a sample absorbance (u) flag indicating a high absorbance for the sample that occurs in conjunction with the (u) flag. amylase results can be generated with these flags.
  • Acción
    Manufacturer to issue advice regarding use

Device

Siemens ADVIA Chemistry Systems, Amylase

Manufacturer

Siemens Healthcare Diagnostics Inc
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    NZMMDSA