Events

Retiro De Equipo (Recall) de Beckman HDL Cholesterol

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
    20115
  • Fecha de inicio del evento
    2016-05-06
  • 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
    There is a possibility that drug interferences from administration of metamizole (dipyrone) to patients may generate false low results., metamizole (dipyrone) has been identified as an interferent which may cause false low results in the following assays: cholesterol osr6x16, triglyceride osr6x118, uric acid osr6x98, lactate osr6x93, enzymatic creatinine osr6x204 and lipase osr6x30. this is a previously undocumented interferent., these interferences are based on a chemical interaction with the trinder reaction, similar to nac interference previously identified by beckman coulter.
  • Acción
    Instructions for use to be updated

Device

Beckman HDL Cholesterol

Manufacturer

manufacturer #1479