Events

Retiro De Equipo (Recall) de ID-Papain Assay. 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-2016-RN-00492-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-04-29
  • 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-2016-RN-00492-1
  • 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
    Following customer complaints, bio-rad has been able to confirm that the affected lots show a decrease in enzymatic activity, leading to false negative or false positive results. bio-rad is recalling the lots identified. this recall is being conducted as a precautionary measure.A risk assessment has been carried out and revealed that difficulty in interpretation of the results involving identification, auto-control and cross-matching in the enzyme technique may be experienced which may result in a delay in transfusion.
  • Acción
    Bio-Rad is advising customers to destroy remaining units of the affected lots, and is recommending using ID-Diluent as an alternative. This action has been closed-out on 03/02/2017.

Device

ID-Papain Assay. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    ID-Papain Assay. An in vitro diagnostic medical device (IVD)Catalogue Number: 005510Lot Numbers: 06311.53.1 (Expiry date 25/04/2016)06311.54.1 (Expiry date 09/05/2016)06311.55.1 (Expiry date 23/05/2016)ARTG Number: 217697
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd