Events

Alerte De Sécurité sur PTS Panels 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 Lynx Technology Limited.

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
    2013-04-24
  • 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_20130424.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 pts panels glucose test strips (with photo) the department of health (dh) today (april 23) directs a local medical device supplier, lynx technology limited (lynx) to recall one lot of the pts panels glucose test strips from consumers as the test strips may give falsely low blood glucose readings. the dh noticed through its surveillance of medical devices that the product's manufacturer, polymer technology systems, inc., has discovered through its product performance surveillance that one lot of the product (lot number: u117) showed falsely low blood glucose readings. a spokesman for the dh explained that falsely low blood glucose readings may mislead a diabetic patient into inappropriate management of his or her condition, resulting in hyperglycemia. according to lynx, some 100 bottles of the affected lot of glucose test strips have been imported into hong kong and distributed to pharmaceutical companies, medical equipment companies and non-governmental organisations, etc. "so far, the dh has not received any local report of adverse events arising from use of the product," the spokesman said. members of the public who may have the affected lot of the test strips in their possession are advised to stop using the product and return their remaining inventory to the local supplier. lynx has set up a hotline 2568 1268 to answer public enquiries on recall arrangements. "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 added. the dh has informed relevant stakeholders about the recall and shall continue to liaise with the supplier on the follow-up actions. ends.

Device

PTS Panels Glucose Test Strips
  • Modèle / numéro de série
  • Description du dispositif
    Press release: Recall of PTS Panels Glucose Test Strips (with photo)
  • Manufacturer
    Lynx Technology Limited

Manufacturer

Lynx Technology Limited