Events

Retiro De Equipo (Recall) de NaCl, Enzyme Test and Cold Agglutinins ID Number: 50520

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-2014-RN-01000-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-09-16
  • 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-2014-RN-01000-1
  • 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
    During an internal investigation, the manufacturer determined that well number 3 of id card nacl, enzyme test and cold agglutinins of the affected lot may contain on a random basis a very small amount of monoclonal anti-e (anti-rh3).
  • Acción
    Bio-Rad is advising users to destroy any remaining affected units if unaffected lots of product are available. As an interim measure, if another lot is not immediately available it is possible to use lot 50520.93.09 with particular attention to the interpretation of positive results: - By manual method, do not use well 3 of the card. - On the automated method, if a positive result is obtained in well 3, use the manual method following the instruction above. This action has been closed-out on 03/06/2016.

Device

NaCl, Enzyme Test and Cold Agglutinins ID Number: 50520
  • Modelo / Serial
    NaCl, Enzyme Test and Cold Agglutinins ID Number: 50520Reference Numbers: 005014 / 005015 / 005016 Batch number : 50520.93.09 with expiry 2016.01ARTG Number: 217697
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd