Events

Retiro De Equipo (Recall) de Bio-Rad D-10 Hemoglobin Testing System

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
    16350
  • Fecha de inicio del evento
    2014-03-05
  • 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
    On a rare occasion the d-10 software might generate an extra result by duplicating the result from the previous sample and the sample id/injection # from the next sample., the duplicate is readily detectable when sorting the daily summary by the injection # and reviewing for duplication of the same sample id number. we recommend carefully reviewing the daily summary and/or the printed chromatograms for duplicate injection numbers or sample ids. such duplication could potentially lead to discrepant sample results, which should not be reported.
  • Acción
    Manufacturer to issue advice regarding use

Device

Bio-Rad D-10 Hemoglobin Testing System
  • Modelo / Serial
    Model: Catalogue Number: 220-0220, Affected:
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479