Events

Rappel de Access 2 Immunoassay System with Software Version 3.4. 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-2013-RN-00469-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-05-17
  • 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-2013-RN-00469-1
  • 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
    Beckman coulter has confirmed that access 2 software version 3.4 has the potential to cause communication errors between the instrument and the console computer that are not recognised by the access 2 system. if this communication error occurs, the system will halt any samples that are in-process and test results will not be imported. the clearing of the communication error cannot be resolved by the customer and the instrument will be inoperable until a service engineer performs a system restore.
  • Action
    If this communication error does occur, immediately contact the Beckman Coulter representative who will perform the necessary procedures to restore the affected system. A Beckman Coulter representative will restore all Access 2 systems to the previous unaffected software version.

Device

Access 2 Immunoassay System with Software Version 3.4. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    Access 2 Immunoassay System with Software Version 3.4. An in vitro diagnostic medical device (IVD)Affected serial numbers: 504105 and 800084
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd