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-00559-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-06-03
  • 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-00559-1
  • 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 confirmed customer reports of the affected lot failing calibration with error condition ocr low. the calibration failures appear to be related to improper shipping or storage conditions.
  • Acción
    Beckman Coulter is requesting end users to discontinue use of the affected lot. Re-assessment of past results is not required as the LACT results produced after acceptable QC recoveries on each reagent cartridge are accurate.

Device

SYNCHRON Systems Lactate (LACT). An in vitro diagnostic medical device (IVD).

Manufacturer

Beckman Coulter Australia Pty Ltd