Events

Retiro De Equipo (Recall) de PrepPlus & PrepPlus 2. 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-00717-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-06-01
  • 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-00717-1
  • 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
    As a result of internal investigations, beckman coulter has confirmed that when samples are prepared using the prepplus or prepplus 2 sample preparation systems and then run on a flow cytometer, there is an imprecision in the absolute counts on only the first tube in a run. there is a software issue where an incorrect volume (aspiration/dispense) of flow-count reagent (used to determine lymphocyte population) is dispensed in the first tube position of the prepplus/prepplus 2 carousel. the issue may generate erroneous results for the reported parameters assayed on the sample in the first tube of the flow count worklist. any sample prepared on the prepplus/prepplus 2 in the first position of the carousel is subject to potential erroneous absolute count results for the reported parameters assayed on the sample in that tube. the potential magnitude of the error is a positive bias of up to 9.7% on the prepplus and 13.4% on the prepplus 2.
  • Acción
    Beckman Coulter will be correcting the issue in the following PrepPlus 2 software release. In the interim, users are requested to insert an empty daughter tube in place of a patient sample as the first tube in the carousel that is programmed for the addition of Flow-Count Fluorospheres (refer to the Coulter PrepPlus Operators Guide or PrepPlus 2 Instructions for Use (IFU) for instructions on adding Flow-Count Fluorospheres to daughter tubes). In addition, users are advised to review all previously generated results with their Medical Director.

Device

PrepPlus & PrepPlus 2. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    PrepPlus & PrepPlus 2. An in vitro diagnostic medical device (IVD)Part Numbers: 286600 & 378600ARTG Number: 177999
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd