Events

Alerte De Sécurité sur Accu-Chek Performa Nano

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

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
    2016-07-19
  • Date de publication de l'événement
    2016-07-19
  • 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_20160719.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: roche accu-chek performa nano the medicines and healthcare products regulatory agency (mhra) of the united kingdom posted a medical device safety alert concerning accu-chek performa nano manufactured by roche diabetes care. the affected lot numbers are 10135127 and 10134053. during internal testing, the manufacturer has detected the code key to be missing in 1,200 accu-chek performa nano kits out of the affected lots. the accu-chek performa nano blood glucose meter cannot be operated without the pre-inserted code key. according to the manufacturer, appropriate corrective measures to the production process have been implemented. new accu-chek performa nano kits will be available shortly. for details, please refer to the mhra website: https://www.Gov.Uk/drug-device-alerts/field-safety-notices-11-july-15-july-2016 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 july 2016.

Device

Accu-Chek Performa Nano
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Roche Accu-Chek Performa Nano
  • Manufacturer
    Roche Diabetes Care

Manufacturer

Roche Diabetes Care