Events

Alerte De Sécurité sur Bar Code Scanner User’s Guide

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 Molecular Inc..

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
    2012-02-01
  • 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_20120202b.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
    Medical Device Safety Alert
  • Cause
    Field safety notice: abbott molecular bar code scanner user’s guide medical device manufacturer, abbott molecular inc., has issued a field safety notice on abbott molecular bar code scanner user’s guide list number: 6l-88-03, 6l88-04, 6l88-05, 6l88-06, 6l88-07, 6l88-08, 6l88-09. according to the manufacturer, internal investigation has identified that within the user’s guide, the section modifying the keyboard format for bar code scanner ln 6l89-01 contains incorrect bar codes that can prevent the correct configuration of the bar code scanner language format. the manufacturer explained that incorrect bar code scanner language configuration could result in the keyboard and bar code scanner not having the same language formats. this could potentially lead to incorrect patient sample identification. independent of this language configuration issue, the bar code scanner is working as expected. the local supplier confirmed that scanners with the affected list numbers have not been distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions.

Device

Bar Code Scanner User’s Guide
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Abbott Molecular Bar Code Scanner User's Guide
  • Manufacturer
    Abbott Molecular Inc.

Manufacturer

Abbott Molecular Inc.
  • 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