Events

Retiro De Equipo (Recall) de Synchron Enzyme Validator - an in vitro diagnostic medical device

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Beckman Coulter Australia 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-2018-RN-00018-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-01-04
  • 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-2018-RN-00018-1
  • 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
    Beckman coulter has identified that a supplemental product information notification is missing from enzyme validator kit lot m612600 due to the introduction of a new lot of traceable reference material in the manufacturing process.As a result, calibration with this lot may demonstrate differences in ast- or ggt patient and control values compared to calibration with previous lots. other enzyme assays are not affected.
  • Acción
    Beckman Coulter is advising affected customers to refer to the Supplemental Product Information provided with the Customer Letter for adjusting set points of AST- and GGT assays.

Device

Synchron Enzyme Validator - an in vitro diagnostic medical device
  • Modelo / Serial
    Synchron Enzyme Validator - an in vitro diagnostic medical deviceReference Number: 441350Lot Number: M612600Expiry: 31/08/2018ARTG: 213974
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd