Events

Rappel de Enzymatic Creatinine, Cholesterol, Uric Acid, Lactate, and Lipase Assays

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-01350-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-12-23
  • 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-01350-1
  • 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
    N-acetyl cysteine (nac), when administered in therapeutic concentrations (for the treatment of acetaminophen overdose), has been recently determined to interfere with the detection of the following analytes on beckman coulter clinical chemistry platforms: enzymatic creatinine, cholesterol, uric acid, lactate, and lipase. nac is an anti-oxidant and can interfere with assays and this may lead to falsely low results and subsequent mistreatment.
  • Action
    The instructions for use will be amended to contain a warning pertaining to patients being treated with N-Acetyl Cysteine (NAC) for a paracetamol overdose may generate false low results for specific tests. This action has been closed-out on 26/08/2016.

Device

Enzymatic Creatinine, Cholesterol, Uric Acid, Lactate, and Lipase Assays
  • Modèle / numéro de série
    Enzymatic Creatinine, Cholesterol, Uric Acid, Lactate, and Lipase AssaysEnzymatic Creatinine Reference Number: OSR6X204Cholesterol Reference Number: OSR6X16Uric Acid Reference Number: OSR6X98Lactate Reference Number: OSR6X93Lipase Reference Number: OSR6X30All lot numbers affected ARTG Number: 200018In Vitro Diagnostic Medical Devices (IVDs)
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd