Events

Retiro De Equipo (Recall) de ID-LISS/Coombs Cards. An in vitro diagnostic medical device (IVD)

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-2015-RN-00314-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-04-13
  • 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-2015-RN-00314-1
  • 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
    Unexpected reactions may rise in the 6th well of lot 50531.95.14 (exp. date 30/06/2016) product id: id-liss coombs cards reference 004017v (24 x 12 id-cards). investigations have identified that a high level of 'broken gel' during a certain time period during filling and only a very limited quantity of id-cards are affected by this phenomenon of unexpected reaction in the 6th well.
  • Acción
    To limit unexpected reactions, customers are asked to stop using the affected boxes (number between 5-1156-288 and 5-1156-318) and to destroy the remaining stock locally. Replacement unaffected stock will be sent.

Device

ID-LISS/Coombs Cards. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    ID-LISS/Coombs Cards. An in vitro diagnostic medical device (IVD)Ref: 004017VLot Number: 50531.95.14 (Exp 30.06.2016)Affected Box numbers: 5-1156-288 to 5-1156-318ARTG number: 217697
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd