Events

Retiro De Equipo (Recall) de BC Synchron Systems Enzymatic Creatininie CR-E

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
    19282
  • Fecha de inicio del evento
    2015-10-21
  • 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
    Beckman coulter has confirmed that n-acetyl cysteine (nac) used in the treatment of acetaminophen overdose may cause assay interference when administered in therapeutic concentrations., the anti-oxidant properties of nac can interfere with assays employing the trinder chemical pathways., the degree of nac interference has been demonstrated to vary depending on the analyte. of the trinder chemical pathway assays, only enzymatic creatinine (cr-e) and uric acid (uric) are affected.
  • Acción
    Instructions for use to be updated

Device

BC Synchron Systems Enzymatic Creatininie CR-E

Manufacturer

Beckman Coulter Inc