Events

Retiro De Equipo (Recall) de Bio-Rad IH-Com Kit Fullversion (Data management and result Interpretation)

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
    13871
  • Fecha de inicio del evento
    2012-12-04
  • 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 case of non interpretable results in the anti-ab well (abo3) of id-cards intended for abo forward grouping, the ih-com software does not include the reaction of this well (result code-30) wheh sending the result to the laboratory host. the issue can only occur if the following conditions are met:, 1. ih-com software is connected to the laboratory host through astm communication mode and,, 2. an "abo not interpretable" result is obtained due to a reaction "?" or "+/-" or "dp" in the anti-abwell of an id-card ** intended forabo forward grouping and, 3. the "second reading" option is deactivated and in-com results are directly sent to the host, or, 4. the "second reading" option is activated but the "not interpretable" result obtained in ih-com is directly saved and sent to the host without a manual selection by the user in abo scrollbar.
  • Acción
    Software to be upgraded

Device

Bio-Rad IH-Com Kit Fullversion (Data management and result Interpretation)
  • Modelo / Serial
    Model: Item number: 09000, Affected: Lot Number: 03.043/03.052/03.0.59
  • Manufacturer
    Bio-Rad Laboratories Inc

Manufacturer

Bio-Rad Laboratories Inc