Events

Retiro De Equipo (Recall) de Sysmex CS-2000i, CS-2100i and CS-5100 Automated blood coagulation analysers

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 Sysmex Corporation.

¿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
    17063
  • 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 a carry-over risk on sysmex cs systems due to the applications using ca-clean i (964-0631-3) for sample probe rinse. under certain circumstances the carry-over might impact results for factor v with innovin®, factor xii with dade® actin® fsl, berichrom f xiii, innovance® d-dimer assays., 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.
  • Acción
    Product to be modified

Device

Sysmex CS-2000i, CS-2100i and CS-5100 Automated blood coagulation analysers
  • Modelo / Serial
    Model: Catalogue number - 10488064, 10488062 and 10709128 respectively, Affected:
  • Manufacturer
    Sysmex Corporation

Manufacturer

Sysmex Corporation