Events

Rappel de Synchron Systems Salicylate Reagent. 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-00844-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-07-12
  • 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-00844-1
  • 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 identified temozolomide, an oral antineoplastic drug used to treat certain types of brain cancers, as a potential source of interference with synchron salicylate reagent (saly).- temozolomide concentrations of 40 mg/l or greater may cause a negative bias in salicylate test results of up to -22%.- the half-life of temozolomide is approximately 1.8 hours, with the active half-life of the metabolite being slightly longer. the probability of an erroneous patient result will be dependent upon the times of administration and dosages of both drugs, salicylate & temozolomide. longer intervals of time between administration of the drugs and the testing will reduce the probability and severity of harm. lower doses of either drug will also reduce the severity of harm. the worst case scenario only occurs if a patient that is overdosed on salicylates is tested within a short period of time after receiving a high dose of temozolomide.
  • Action
    No immediate action is required by laboratories other than being aware of this issue as the IFU is being updated. Beckman Coulter is not recommending a retrospective review of prior test results.

Device

Synchron Systems Salicylate Reagent. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    Synchron Systems Salicylate Reagent. An in vitro diagnostic medical device (IVD)Reference Number: 378194All LotsARTG Number: 185654
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd