Events

Rappel de Ultrasonic Transducer Kits used with the Access Family of Immunoassay Systems. 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-2014-RN-00562-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-05-21
  • 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-2014-RN-00562-1
  • 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 determined that some ultrasonic transducer kits were potentially assembled with incorrect mounting screws. one of these transducers may have been installed on the system during a recent instrument repair. over time the screws can become loose if a combination of correct and incorrect screws are used and possibly cause incorrect probe wash, splashing in the reaction vessels (rv), incorrect particle suspension in the reagent pack, or incorrect rv mix due to alignment of the probe to wash tower/rv leading to assay imprecision. this may cause erraneous but believable results and/or delay of results due to transducer alignment error.
  • Action
    Users are advised to review historical QC data and System Check results since the transducer was installed for any indication of a potential problem and determine whether a review of patient test results is warranted. A service representative will be contacting users to schedule a service visit to confirm that their transducer is properly installed.

Device

Ultrasonic Transducer Kits used with the Access Family of Immunoassay Systems. An in vitro diagno...
  • Modèle / numéro de série
    Ultrasonic Transducer Kits used with the Access Family of Immunoassay Systems. An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd