Events

Alerte De Sécurité sur TRUEtrack and TRUEtest Blood Glucose Test Strips

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

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
    2016-07-20
  • Date de publication de l'événement
    2016-07-20
  • 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_20160720.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: truetrack and truetest blood glucose test strips the health canada has posted a medical device safety alert concerning the truetrack and truetest blood glucose test strips, manufactured by trividia health, inc. the model and lot numbers affected by this issue are described below: truetrack blood glucose test strips [model number: a3i20-80, a3i20-81; lot number: rs4567ica, rs4704ica] truetest blood glucose test strips [model number: e3i20-80, e3i20-81; lot number: ps2284ica, ps2316ica, ps2335ica] a limited number of sealed test strip vial boxes from certain blood glucose test strip lots may include an open test strip vial. test strips contained within open vials are exposed to the outside environment, which can affect strip performance. in particular, test strips exposed to the environment may provide incorrect low blood glucose results. according to the manufacturer, inaccurate low blood glucose results may lead to undetected hyperglycemia (high blood glucose) and result in improper treatment. for details, please refer to the health canada’s websites: http://healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2016/59384r-eng.Php if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 20 july 2016.

Device

TRUEtrack and TRUEtest Blood Glucose Test Strips
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: TRUEtrack and TRUEtest Blood Glucose Test Strips
  • Manufacturer
    Trividia Health

Manufacturer

Trividia Health