Events

Rappel de ALT and Glucose-Stat Assays (used for the determination of ALT and Glucose). 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-00758-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-06-10
  • 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-00758-1
  • 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
    Previously unknown drug interferences from sulfasalazine and sulfapyridine have been identified. there is a possibility that drug interference's from administration of sulfasalazine to patients may generate false low alt results and false low glucose-stat results. sulfapyridine may generate false high glucose-stat results (osr6x40).Interference seen with 300mg/l sulfasalazine showed a negative bias of up to 35% for the low alt control and up to 29% for the high alt control.Interference seen with 300mg/l sulfasalazine showed a negative bias of up to 25% (or 1.3 mmol/l) for the low glucose-stat control and up to 13% (or 1.6mmol/l) for the high glucose-stat control.Interference seen with 300mg/l sulfapyridine showed a positive bias of up to 21% (or 1.1 mmol/l )for the low glucose-stat control and up to 9% or (1.1mmol/l) for the high glucose-stat control.There is no risk to patients however there is the potential for a delay in results.
  • Action
    Beckman Coulter is advising users that the IFU has been updated to include additional warnings in the 'Interfering Substances' section. No retrospective review of results is recommended.

Device

ALT and Glucose-Stat Assays (used for the determination of ALT and Glucose). An in vitro diagnost...
  • Modèle / numéro de série
    ALT and Glucose-Stat Assays (used for the determination of ALT and Glucose). An in vitro diagnostic medical device (IVD)Reference numbers: ALT OSR6X07, Glucose-Stat OSR6X40All lots affectedARTG numbers: 200015, 200018
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd