Events

Alerte De Sécurité sur GenStrip 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 N/A.

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
    2014-04-30
  • 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_20140430.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
    Safety alert over genstrip blood glucose test strips the department of health (dh) today (april 30) drew public attention to a safety alert concerning a glucose test strip called genstrip blood glucose test strips. the test strip, manufactured and sold by shasta technologies llc, may report incorrect blood glucose readings. the dh, through its routine surveillance on medical devices, noticed the above alert issued by the us food and drug administration (fda). the test strips concerned are advertised for use with the lifescan onetouch family of glucose meters (e.G. ultra, ultra 2 and ultra mini) manufactured by another medical device manufacturer, johnson and johnson. according to the alert, the fda found extensive violations of relevant regulations intended to assure the quality of products in the manufacturing of the test strips during a recent inspection of shasta technologies llc. as the company did not have in place many of the requirements of a quality system, the fda believes that the strips could report incorrect blood glucose levels. a spokesman for the dh explained that false blood glucose readings may mislead a diabetic patient into inappropriate management of his or her condition, resulting in hypoglycaemia or hyperglycemia. the dh is investigating whether genstrip blood glucose test strips have been imported into hong kong. as the lifescan onetouch family of glucose meters is available for sale locally, there is also a possibility that some patients may have purchased the affected test strips abroad or from the internet for their own use. the dh hence advises the public to stop using the product concerned and switch to alternative blood glucose test strips which are designed for use with the lifescan onetouch family of glucose meters. so far, the dh has not received any local report of adverse events arising from use of the product. ends.

Device

GenStrip Blood Glucose Test Strips
  • Modèle / numéro de série
  • Description du dispositif
    Press release: Safety alert over GenStrip Blood Glucose Test Strips
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    DH