Events

Retiro De Equipo (Recall) de Bio-Rad Urinary Catecholamines by HPLC Reagent Kit

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 Bio-Rad Laboratories 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
    14031
  • Fecha de inicio del evento
    2012-12-28
  • 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: Bio-Rad Laboratories Ltd, 189 Bush Road, Rosedale, AUCKLAND 0632
  • Causa
    In some urine samples the concentration of adrenaline/epinephrine may decrease when analysis time is >8 hours., this decrease in concentration occurs only, if samples were subsequently adjusted to ph 5 to ph 7 as described in the instruction for use for very acidic samples or samples with low 24-volumes., there is a risk of false negative result being reported when samples experience these conditions.
  • Acción
    Instructions for use to be updated

Device

Bio-Rad Urinary Catecholamines by HPLC Reagent Kit

Manufacturer

Bio-Rad Laboratories Inc