Events

Alerte De Sécurité sur Optium Omega 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
    2011-01-11
  • 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_20110111.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
    Resumption of sale of abbott's optium omega glucose test stripsthe department of health (dh) has today (january 11) agreed to allow one brand of abbott's glucose test strips, optium omega, to re-enter the market. a spokesman for dh said that the decision was based on consideration of information in hand, especially the differences in design and manufacturing of optium omega and the supply of alternatives on the market. dh, through its routine surveillance system, captured a us food and drug administration (fda) alert about the recall of over 380 lots, involving some 10 brands, of glucose test strips marketed by abbott diabetes care in the us late last december.? this is due to ineffectiveness of the strips - there are possibilities of obtaining falsely low blood glucose readings instead.? to allow time for proper investigation and as a precautionary measure to safeguard hong kong's public health, dh requested the local medical device supplier, abbott laboratories limited, to recall all its glucose test strips from consumers on december 29 last year. "as optium omega's unique design and manufacturing could ensure its exemption from ineffectiveness, dh thinks it reasonable to allow its re-entry into the local market, especially alternatives are not in abundance here in hong kong," a dh spokesman explained. "however, any time users are in doubt of the accuracies, they should stop using the strips and consult their healthcare providers," he further remarked. dh would continue to follow-up with the investigation and also closely monitor the recall of other brands of abbott’s glucose test strips. ends/tuesday, january 11, 2010.

Device

Optium Omega glucose test strips
  • Modèle / numéro de série
  • Description du dispositif
    Press release: Resumption of Sale of Abbott's Optium Omega glucose test strips
  • Manufacturer
    Abbott Laboratories

Manufacturer

Abbott Laboratories
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • 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
    DH