Events

Rappel de HemoCue Glucose 201 RT Microcuvettes (used with HemoCue Glucose 201 RT and HemoCue Glucose 201 RT DM analysers). 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 Radiometer Pacific 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-00237-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-03-09
  • 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-00237-1
  • 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
    Hemocue has recently become aware of a production related problem that affects hemocue glucose 201rt microcuvettes. during an internal investigation a minor deviation was found, which may cause the microcuvettes to not perform as intended. there was an incorrect position for the sleigh in the final punch which affects the grouping of cuvettes with respect to measuring level. the accuracy of glucose levels below 4.1mmol/l may deviate by up to +0.9 mmol/l, resulting in falsely high results. there is also a low possibility that results in the range of 6.6-8.8 mmol/l may be falsely elevated.No harm to patients has been reported. however, there is a risk that a false high result for low glucose levels could lead to delayed or missed diagnosis of hypoglycaemia, as clinical symptoms are not always present.
  • Action
    Radiometer is advising users that the affected product can continue to be used in adults. The affected lots should not be used in neonates or infants. Users should verify low or marginal results via another method.

Device

HemoCue Glucose 201 RT Microcuvettes (used with HemoCue Glucose 201 RT and HemoCue Glucose 201 RT...
  • Modèle / numéro de série
    HemoCue Glucose 201 RT Microcuvettes (used with HemoCue Glucose 201 RT and HemoCue Glucose 201 RT DM analysers). An in vitro diagnostic medical device (IVD)Product Code: 114701Batch Numbers: 1506998, 1507909, 1508920, 1405990, 1407901, 1410921, 1411931, 1501939, 1501950, 1504972, 1506995 ARTG Number: 222660
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd