Events

Rappel de Dimension Creatinine and Dimension Vista Creatinine 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 Siemens Healthcare 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-2015-RN-00680-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-07-28
  • 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-2015-RN-00680-1
  • 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
    Siemens healthcare diagnostics has determined that dimension creatinine (crea) may produce depressed results up to 12.7% (or approximately 18 µmol/l) for a creatinine result at 133 µmol/l when haemolysis exceeds 300 mg/dl [0.19 mmol/l] of haemoglobin. dimension vista creatinine (crea) may produce depressed results up to 22% (or approximately 27 ìmol/l) for a creatinine result at 133 ìmol/l when haemolysis exceeds 200 mg/dl [0.12 mmol/l] of haemoglobin.Depressed creatinine results due to haemolysis would not be expected to significantly impact medical decisions when using this assay. the potential for injury is remote due to continued monitoring, additional diagnostic testing and correlation to patient history and presentation.
  • Action
    A workaround is provided in the form of revised interference information via the Customer Letter.

Device

Dimension Creatinine and Dimension Vista Creatinine Assays
  • Modèle / numéro de série
    Dimension Creatinine and Dimension Vista Creatinine AssaysDimension CREA AssayCatalogue Number: DF33A Siemens Material Number (SMN): 10444968Dimension Vista CREA AssayCatalogue Number: K1033 Siemens Material Number (SMN): 10445161All in-date and future lots are affectedARTG number: 181689
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Société-mère du fabricant (2017)
    Siemens AG
  • Source
    DHTGA