Events

Rappel de Multiple Assay for Enzymatic Creatinine, Cholesterol, Triglyceride, Uric Acid, Lactate, Lipase. 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-00577-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-05-11
  • 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-00577-1
  • 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
    There is a possibility that drug interferences from administration of metamizole (dipyrone) to patients may generate false low results. metamizole (dipyrone) has been identified as an interferent which may cause false low results in certain assays. this is a previously undocumented interferent.These interferences are based on a chemical interaction with the trinder reaction, similar to nac interference previously identified by beckman coulter and may result in an error in diagnosis or patient management.No customer complaints have been received for this particular issue.
  • Action
    Beckman Coulter is providing users with updated Instructions for Use (IFU) to follow in order to avoid any potential interferences. A review of previously generated patients results is at the discretion of the Laboratory Director.

Device

Multiple Assay for Enzymatic Creatinine, Cholesterol, Triglyceride, Uric Acid, Lactate, Lipase. A...
  • Modèle / numéro de série
    Multiple Assay for Enzymatic Creatinine, Cholesterol, Triglyceride, Uric Acid, Lactate, Lipase. An in vitro diagnostic medical device (IVD)Product Codes: OSR6X204, OSR6X16, OSR6X118, OSR6X98, OSR6X93, OSR6X30All lot numbers affectedARTG Numbers: 200018, 200015
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd