Alerte De Sécurité sur 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 Abbott Laboratories.

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
  • Pays de l'événement
  • Source de l'événement
  • URL de la source de l'événement
  • 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 abbott's glucose test stripsthe department of health (dh) has directed local supplier abbott laboratories limited to recall 359 lots of glucose test strips which may give falsely low blood glucose results today (december 23). the recall followed assessment of a us food and drug administration (fda) alert, captured by dh's routine surveillance system, which involved the recall of 359 different lots of glucose test strips marketed by abbott diabetes care in the us under the following brand names: * precision xceed pro; * precision xtra; * medisense optium; * optium; * optiumez; and * relion ultima the blood glucose monitoring systems are not affected by this recall. more details of the recall are posted under fda news (medical devices) and the abbott diabetes care respectively: http://www.Fda.Gov/newsevents/newsroom/ pressannouncements/ucm237900.Htm http://www.Precisionoptiuminfo.Com/img/lot-numbers.Pdf according to initial information from the local supplier, at least the following items and lot numbers in the list of test strips are available in hong kong: medisense optium blood glucose electrodes * lot 45001a137 * lot 45001a921 precision xceed pro blood glucose test strips * lot 44cr5h abbott's records revealed that some 6,000 boxes of the above lots are available in hong kong. a spokesman for dh said although records showed that only three lots were shipped to hong kong, it was necessary to recall all 359 lots of products as some products might have been directly brought back to hong kong by consumers or purchased over the internet. so far, the dh has not received any report of adverse events arising from the affected products. members of the public should stop using any of the 359 lots of products and contact healthcare professionals if in doubt. they may contact the company at hotline 2806 4488 daily from 9am to 5pm for recall arrangements. hospitals, medical associations and nursing homes have been alerted. the department will closely monitor the recall. investigation continues.   thursday, december 23, 2010.



  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source