Events

Retiro De Equipo (Recall) de Siemens ADVIA Centaur Folate

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
    16467
  • Fecha de inicio del evento
    2014-03-28
  • 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
    Manufacturer has confirmed two different sets of complaints regarding the advia centaur systems folate asay:, folate lot 223: siemens confirmed one set of customer complaints with the advia centaur systems folate assay, kit lots ending in 223. customers observed that the bio-rad liquichek™ and bio-rad lyphochek™ immunoassay plus folate serum controls may go out of range low with the advia centaur systems folate assay, kit lots ending in 223., folate lot 219 whole blood bias: in addition, siemens has confirmed a second set of customer complaints regarding a shift in whole blood patient results when moving from advia centaur systems folate assay, kit lots ending in 219 to kit lots ending in 222, 224, 225, 226 and/or 227.
  • Acción
    Product to be destroyed

Device

Siemens ADVIA Centaur Folate
  • Modelo / Serial
    Model: 10310308 10325366 10331250 and 10340209, Affected: kit lots ending in 219, 222, 223, 224, 225, 226 and 227
  • Manufacturer
    Siemens Healthcare Diagnostics Inc

Manufacturer

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