Events

Rappel de TRUEresult Blood Glucose Test Strip (10 counts) (used with the TRUEresult Blood Glucose Monitoring System). 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 Nipro 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-00632-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-05-18
  • 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-00632-1
  • 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
    This recall has been initiated as a limited number of sealed test strip vial boxes from the affected trueresult blood glucose test strip batch may include an open test strip vial. test strips contained within open vials are exposed to the outside environment, which can adversely affect the strips performance. in particular, test strips exposed to the environment may provide falsely low blood glucose results. falsely low blood glucose results may lead to undetected hyperglycemia (high blood glucose) and result in improper treatment.Action based on falsely low results may raise blood glucose levels further, resulting in potentiated hyperglycemia which may require medical intervention.
  • Action
    Nipro is advising users to inspect stock and quarantine any remaining stocks of the affected batch for return. This action has been closed-out on 03/02/2017.

Device

TRUEresult Blood Glucose Test Strip (10 counts) (used with the TRUEresult Blood Glucose Monitorin...
  • Modèle / numéro de série
    TRUEresult Blood Glucose Test Strip (10 counts) (used with the TRUEresult Blood Glucose Monitoring System). An in vitro diagnostic medical device (IVD) Item Number: E4i08-81FDExpiry Date: 25/06/2018Batch Number: KS1741ARTG Number: 180121
  • Manufacturer
    Nipro Australia Pty Ltd

Manufacturer

Nipro Australia Pty Ltd