Events

Alerte De Sécurité sur EUKARE Blood Glucose Test Strip

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

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
    2012-03-05
  • 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_20120306.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 eukare blood glucose test strip the department of health (dh) today (march 5) drew public attention to the recall of certain lots of a blood glucose test strip, the eukare blood glucose test strip. the affected test strips may give falsely high blood glucose readings. the dh noticed through its surveillance of medical devices that the product's manufacturer, eumed biotechnology co. ltd., has recalled two lots of the products (lot numbers: ts14dd1f1002 and ts16dd1h2814). information from the manufacturer indicates that the problem appears to be related to improper storage of a reagent of the test strips. a spokesman for the dh explained that falsely high blood glucose readings may mislead a diabetic patient into inappropriate management of his or her condition, resulting in hypoglycaemia. according to the manufacturer, the eukare blood glucose test strip has not been imported into hong kong. so far, the dh has not received any local report of adverse events arising from use of the product. "though the affected product has not been introduced into the hong kong market, and we have no record of related adverse events here, the possibility of individual diabetic patients having somehow obtained the product from abroad justifies a public alert, in our opinion," the spokesman said. members of the public who may have the above test strips in their possession are advised to stop using the product and surrender them to the dh's medical device control office at room 3101, 31/f, hopewell centre, 183 queen's road east, wan chai. "for those customers who have used the said product and are either feeling unwell or in doubt, they should consult their health-care professionals for advice as soon as possible," the spokesman said. ends.

Device

EUKARE Blood Glucose Test Strip
  • Modèle / numéro de série
  • Description du dispositif
    Press release: Recall of EUKARE Blood Glucose Test Strip
  • Manufacturer
    Eumed Biotechnology Co. Ltd.

Manufacturer

Eumed Biotechnology Co. Ltd.
  • Source
    DH