Events

Retiro De Equipo (Recall) de Pre-Transfusion Blood Testing System PK7300 Automated Microplate System. 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-2017-RN-00798-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-06-26
  • 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-2017-RN-00798-1
  • 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 that, during sample processing under certain conditions, the pk7300 does not always generate a reagent dispensing pressure error when the reagent vial becomes empty and no reagent is dispensed. sample processing will continue after a vial is empty only when the reagent alarm volume, limit volume and associated mode shift alarm have not been set.False negative test results with blood grouping reagents may occur. results will not be generated for tests using cellular or particle reagents. wells without cellular or particle reagents will be flagged as empty (.E flags).
  • Acción
    Beckman Coulter is requesting that customers verify that all of the following are set on all PK7300 analysers in their laboratory: 1. Alarm Volume and Limit Volume in the Common Test Parameter – Name (Reagent tab) menu. 2. Either “To Pause” or “To Measure 2” is selected for “at Short Reagent Volume Alarm” on the Mode Shift tab in the System – System Menu. If the parameters described above have not been set on all PK7300s in your laboratory, please follow the instructions in the PK7300 User’s Guide and the information in the customer letter to set them. When reagent vials are placed in the reagent tray, make sure that each vial is fully seated to the bottom of the tray.

Device

Pre-Transfusion Blood Testing System PK7300 Automated Microplate System. An in vitro diagnostic m...
  • Modelo / Serial
    Pre-Transfusion Blood Testing System PK7300 Automated Microplate System. An in vitro diagnostic medical device (IVD)ARTG Number: 177999
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd