Events

Retiro De Equipo (Recall) de Beckman Coulter ALT

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 Beckman Coulter 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
    20263
  • Fecha de inicio del evento
    2016-06-13
  • 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: Beckman Coulter NZ Ltd, Suite 2, Level 4, 30 St Benedicts Street, Newton, AUCKLAND
  • Causa
    Previously unknown drug interferences from sulfasalazine and sulfapyridine have been identified., alt and glucose-stat are ivd products designed for the quantitative determination of alanine aminotransferase (alt) or glucose on the beckman coulter au series of analysers., there is a possibility that drug interferences from administration of sulfasalazine to patients may generate false low (alt) results and false low glucose-stat results ., sulfapyridine may generate false high glucose-stat results.
  • Acción
    Software to be upgraded

Device

Beckman Coulter ALT
  • Modelo / Serial
    Model: OSR6007 OSR6107 OSR6507 and OSR6607, Affected: All Lots
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc