Events

Rappel de Dimension Vista Hemoglobin A1c 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-01030-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-09-25
  • 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-01030-1
  • 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 has confirmed that the dimension hb1c flex reagent cartridge lots listed1 exhibit a positive bias averaging 0.4% [4.4 mmol/mol] haemoglobin a1c units and occasionally up to 1.0% [11 mmol/mol] hba1c units for patient samples when compared to the national glycohemoglobin standardization program (ngsp).
  • Action
    Siemens is advising their customers to discontinue use and discard the affected lots. Retesting HbA1c should be considered in cases where all of the following events have occurred: - HbA1c testing was performed on your patient(s) using the affected lot numbers - There may have been adjustments in therapy based solely on the HbA1c value(s), - There have been no follow up HbA1c testing on the patient since the discontinuation of use of the affected lot numbers. This action has been closed-out on 10/08/2016.

Device

Dimension Vista Hemoglobin A1c Flex Reagent Cartridge. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    Dimension Vista Hemoglobin A1c Flex Reagent Cartridge. An in vitro diagnostic medical device (IVD)Catalogue Number: DF105ASiemens Material Number: 10483822Lot Numbers: GA4266, BA4273, BA4280, BA4287, GA4301, GA4315, GC4322, GA4343, GA4350, GA4357, GA5013 & GA5020ARTG Number: 181689
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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