Events

Alerte De Sécurité sur HemoCue Glucose 201 Microcuvettes single packed

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par HemoCue AB.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2014-11-12
  • Date de publication de l'événement
    2014-11-12
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141112.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: hemocue glucose 201 microcuvettes single packed the australia therapeutic goods administration (tga) posted a medical device safety alert concerning hemocue glucose 201 microcuvettes single packed manufactured by hemocue ab. the affected article number is 110718 and the affected lot number is 1310798. the manufacturer has become aware that the hemocue glucose 201 microcuvette may, at the end of their shelf-life, yield measurements higher than expected. the higher glucose values may have led to unnecessary insulin treatment or lack of glucose treatment. according to the manufacturer, the microcuvettes of this specific lot number have now passed their expiry date and should have been used, or be discarded. the manufacturer recommends users that the need for repeat testing be determined by the laboratory or clinical director. for details, please refer to the following link: http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2014-rn-01197-1 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 12 november 2014.

Device

HemoCue Glucose 201 Microcuvettes single packed
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: HemoCue Glucose 201 Microcuvettes single packed
  • Manufacturer
    HemoCue AB

Manufacturer

HemoCue AB