Events

Retiro De Equipo (Recall) de SYNCHRON Systems Lactate (LACT), 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 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-2013-RN-00364-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-04-22
  • 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-2013-RN-00364-1
  • 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 received customer reports of suppressed lact results for samples containing lact concentration of 6.5 mmol/l or greater, when using the affected lot number. internal testing confirmed that the issue for samples containing lact concentrations between 9.2 and 11.0 mmol/l. although these results are within the analytical range of 0.3 - 11.0 mmol/l, the results are suppressed and the system identifies the error condition rxn rate hl.
  • Acción
    Beckman Coulter is asking users to cease using the affected lot and is offering a replacement.

Device

SYNCHRON Systems Lactate (LACT), An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    SYNCHRON Systems Lactate (LACT), An in vitro diagnostic medical device (IVD)Reference: A95550Lot Number: M206209Expiry: 2013-04-30
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd