Events

Rappel de IRISpec CA/CB/CC and IRISpec CA/CB Control Kits (quality control for the detection of Bilirubin). 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-2016-RN-00437-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-04-14
  • 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-2016-RN-00437-1
  • 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
    The manufacturer, iris international has become aware of an issue in which premature degradation of bilirubin for specific lots may lead to bilirubin control failures for the irispec ca bilirubin control material. the control may fail for the bilirubin analyte and laboratories will be unable to process patient samples until qc passes.
  • Action
    Beckman Coulter is advising users to ensure the directions for handling and storage of the control material as per the IFU are followed to prevent premature degradation of the control material. Users are advised to discard the bottle if the QC fails and use alternative bottles in the kit. If the problem persists, request a product replacement from Beckman Coulter. This action has been closed-out on 03/02/2017.

Device

IRISpec CA/CB/CC and IRISpec CA/CB Control Kits (quality control for the detection of Bilirubin)....
  • Modèle / numéro de série
    IRISpec CA/CB/CC and IRISpec CA/CB Control Kits (quality control for the detection of Bilirubin). An in vitro diagnostic medical device (IVD)Reference Number: 800-7211Lot Numbers: 336-15, 343-15 (Exp April 2016) Lot Numbers: 004-16,006-16,019-16,021-16,182-15 (Exp May 2016)Reference Number: 800-7702Lot Numbers: 313-15, 336-15 (Exp April 2016) Lot Numbers: 004-16 (Exp May 2016)Reference Number: 800-7211Lot Number: 309-15 (Exp April 2016)ARTG Number: 177551
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd