Events

Rappel de Nova StatStrip and StatSensor Blood Monitoring Systems. An in vitro diagnostic medical device (IVD)(Point of Care System)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Australasian Medical & Scientific 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-2013-RN-01322-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-12-16
  • 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-2013-RN-01322-1
  • 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 action is to alert users that lithium batteries utilized beyond their intended useful life may swell and/or crack the external case posing a potential safety hazard. in some cases, the swelling may cause the battery door on the meter to incorrectly seat rendering the meter inoperable.
  • Action
    AMSL is advising users that all batteries without an expiration date label will be replaced. AMSL recommends a battery inspection program is implemented to identify and remove batteries from point of use that do not have expiration dates on the battery label.

Device

Nova StatStrip and StatSensor Blood Monitoring Systems. An in vitro diagnostic medical device (IV...
  • Modèle / numéro de série
    Nova StatStrip and StatSensor Blood Monitoring Systems. An in vitro diagnostic medical device (IVD)(Point of Care System)ARTG Number: 197482
  • Manufacturer
    Australasian Medical & Scientific Ltd

Manufacturer

Australasian Medical & Scientific Ltd