Events

Alerte De Sécurité sur i-sens Model CareSens II

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

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
    2009-04-23
  • 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/press_20090424.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
    Press release
  • Cause
    Recall of blood glucose meters with incorrect readings (i-sens model caresens ii) the department of health today (april 23) alerted the public and the medical sector, of a voluntary recall of a type of blood glucose meter (bgm)which displayed falsely low readings. dh immediately looked into the case upon receiving notification from an informant that two bgm manufactured by i-sens inc, were found to display falsely low readings. it was revealed that only one specific lot (lot no. isp11e02101 – isp11e02600) of the bgm was affected. the manufacturer, i-sens inc, has initiated a voluntary recall through its distributor, bioscan ltd. according to bioscan ltd, there were 150 bgm of the affected lot imported to hong kong and 106 bgm to macao respectively. dh has notified the health bureau of macao of the recall. users should not use the blood glucose meters of the affected lot and seek advice from their doctors. the department has not received any report of adverse events arising from this issue. dh will closely monitor the recall. the spokesman said people using the meters concerned should contact the company by calling its hotline (3589 6670) during office hours for replacement. ends/thursday, april 23, 2009.

Device

i-sens Model CareSens II
  • Modèle / numéro de série
  • Description du dispositif
    Press release: Voluntary Recall of blood glucose meters with incorrect readings (i-sens Model CareSens II)
  • Manufacturer
    i-SENS Inc

Manufacturer

i-SENS Inc