Events

Retiro De Equipo (Recall) de Liquichek Diabetes Control

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Bio-Rad Laboratories Pty Ltd.

¿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
    RC-2017-RN-00267-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-02-27
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00267-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Bio-rad has observed that the values for the analyte haemoglobin a1c may gradually decrease over the shelf life of certain product lots.
  • Acción
    Bio-Rad advises:- 1. Laboratory means and acceptable ranges may need to be re-established for HbA1C during the shelf life of the product; 2. Users are requested to obtain a revised copy of the Liquichek Diabetes Control package insert through the Internet at http://myeinserts.qcnet.com Discard all previous versions of the package insert for these lots of product that they may have at each location and substitute those with the revised package insert.

Device

Liquichek Diabetes Control
  • Modelo / Serial
    Liquichek Diabetes ControlMaster Lot Numbers: 38530, 38540, 38530VLevels: 1, 2, 3 and MiniPakCatalogue Numbers: 171, 172, 173, 172X, 291, 292, 293, 292XARTG Number: 198363
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd