Events

Rappel de Dimension Vista Systems - Theophylline (THEO) Flex Reagent Cartridge. 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 Siemens Ltd Diagnostics Division.

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-01206-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2014-11-13
  • 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-01206-1
  • 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 confirmed abnormal reaction flags (e145: abnormal reaction) with dimension vista theophylline (theo) flex reagent cartridge lot 14148ac. the abnormal reaction flags can occur on calibration, qc and/or patient samples. any result with an abnormal reaction flag is deemed non-reportable as described in the dimension vista operator’s guide.The potential for an abnormal reaction flagged result when using the affected lots would prevent reporting theophylline values. the frequency of obtaining abnormal reaction flags as a result of this issue is variable among customer sites ranging from 0 flags to 100% of results flagged.
  • Action
    Siemens is requesting their customers to discontinue use and discard any remaining inventory of Dimension Vista THEO lot 14148AC. Siemens will replace any unused inventory of the affected lot at no charge. This action has been closed-out on 02/03/2016.

Device

Dimension Vista Systems - Theophylline (THEO) Flex Reagent Cartridge. An in vitro diagnostic medi...
  • Modèle / numéro de série
    Dimension Vista Systems - Theophylline (THEO) Flex Reagent Cartridge. An in vitro diagnostic medical device (IVD).Catalogue Number: K4071Lot Number: 14148ACARTG Number: 182220
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division
  • Société-mère du fabricant (2017)
    Siemens AG
  • Source
    DHTGA