Events

Rappel de PrepPlus & PrepPlus 2. An in vitro diagnostic medical device (IVD)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Beckman Coulter Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2017-RN-00717-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-06-01
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00717-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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)
  • Modèle / numéro de série
    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