Events

Retiro De Equipo (Recall) de Beckman Coulter LH 750 & 780 Hematology Analysers (An in vitro diagnostic 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-01019-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-09-27
  • 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-01019-1
  • 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
    An internal investigation indicates that specific lots of check valves used in several locations within the lh 750 and lh 780 analysers may fail. this failure may result in air or liquid leak at the connection to the vacuum overflow tank waste line or at the backwash tank drain line. there is a remote risk of reporting false high or false negative results for all parameters on control and patient samples if the backwash tank fails to refill after manual aspiration. there is also a risk for a leak of biohazardous waste if the check valve fails at the vacuum overflow tank waste line. this risk is limited to samples analysed using the manual aspiration mode.
  • Acción
    Beckman Coulter is recommending users review manual mode sample results if the "Backwash Tank Not Full" error occurs for all samples obtained since the last acceptable QC run. Beckman Coulter is advising users to avoid physical contact with a possible leak and follow personal protective equipment (PPE) guidelines as recommended in the Instructions for Use (IFU). Beckman Coulter will be contacting all sites to arrange an on-site visit to inspect valves and replace any affected valves.

Device

Beckman Coulter LH 750 & 780 Hematology Analysers (An in vitro diagnostic device (IVD))
  • Modelo / Serial
    Beckman Coulter LH 750 & 780 Hematology Analysers (An in vitro diagnostic device (IVD))Beckman Coulter LH 750 Hematology AnalyserProduct Numbers: 6605632 & A85570Beckman Coulter LH 780 Hematology AnalyserProduct Numbers: 723585 & A90728ARTG Number: 177999
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd