Events

Rappel de AVOXimeter 1000E Cuvettes (used for oximetery assessment during heart catheterisation procedures). 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 Zoll Medical 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-01265-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-09-29
  • 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-01265-1
  • 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
    It has been determined that a limited number of avoxmeter 1000e cuvettes have exceeded internal control limits for gap measurement. the gap measurement is incorporated into the pathlength value, which in turn is entered into the settings of avoximeter instruments when a new lot of cuvettes are used to run a test. the pathlength values add an additional degree of accuracy in the total haemoglobin (thb) reported value and those calculations where thb is used as a variable. the pathlength values do not affect %02hb, %cohb or %methb results.The affected avoximeter cuvettes may have a slight upward shift in pathlength that can result in a clinically insignificant corresponding downward shift in thb. in a worst case, this shift may cause the reporting of a thb result approximately 5% lower than the actual thb value (e.G. an actual value of 10 g/dl is reported as 9.5 g/dl). the shift presents a low risk to health in the intended clinical uses associated with the avoximeter system.
  • Action
    Zoll Medical is advising users of the possibility of a downward shift in tHb values with the affected lots.

Device

AVOXimeter 1000E Cuvettes (used for oximetery assessment during heart catheterisation procedures)...
  • Modèle / numéro de série
    AVOXimeter 1000E Cuvettes (used for oximetery assessment during heart catheterisation procedures). An in vitro diagnostic medical device (IVD).Product Code: C100BLot Numbers: 607-108, 607-109, 607-110, 607-111, 607-112, 607-114, 607-115, 607-116, 607-117, 607-118, 607-119, 607-120, 607-122, 607-123, 607-124ARTG Number 262423
  • Manufacturer
    Zoll Medical Australia Pty Ltd

Manufacturer

Zoll Medical Australia Pty Ltd