Events

Retiro De Equipo (Recall) de Siemens RAPIDPoint® 400 and and RAPIDPoint® 405 Measurement Cartridge

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
    20623
  • Fecha de inicio del evento
    2016-09-08
  • 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
    An error in the value assignment for the chloride calibrators in the rapidpoint 400 and rapidpoint 405 measurement cartridge serial numbers 2610900214 through to 2621001325 has been identified. at extremely high chloride values (>122nmol/l) a positive bias of 5% or greater may be observed. chloride values should be interpreted in the context of all serum electrolytes (sodium, bicarbonate) and acid base status.
  • Acción
    Manufacturer to issue advice regarding use

Device

Siemens RAPIDPoint® 400 and and RAPIDPoint® 405 Measurement Cartridge
  • Modelo / Serial
    Model: 0329756, 10341161, 10844812, 10283222, 10313971 and 10310469, Affected:
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479