Events

Retiro De Equipo (Recall) de Siemens Sysmex CS-2000i, CS-2100i, CS-2500 and CS-5100 Systems

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
    21041
  • Fecha de inicio del evento
    2018-07-10
  • 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
    The manufacturer has confirmed that under very rare circumstances a false negative result may be reportable. the issue may only occur under the following conditions:, 1. the initial result is falsely flagged with an antigen excess error that triggers an automatic reanalysis in a 1/19 dilution., 2. the raw signal that is generated from the reanalysis is below the limit of blank (lob) of the method., follow-up communication, the manufacturer has issued a new protocol disc version with new and enhanced assay applications for sysmex cs-2000i/cs-2100i systems. this also includes a new protocol disc version with new and enhanced assay applications for sysmex cs-2500 systems and on sysmex cs-5100 systems.
  • Acción
    Manufacturer to issue advice regarding use

Device

Siemens Sysmex CS-2000i, CS-2100i, CS-2500 and CS-5100 Systems

Manufacturer

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