Events

Alerte De Sécurité sur BD BBL DrySlide PYR Kit and BD BBL DrySlide Oxidase Kit

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par BD.

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
    2013-04-26
  • Date de publication de l'événement
    2013-04-26
  • 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_20130426c.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
    Medical device safety alert: bd bbl dryslide pyr kit and bd bbl dryslide oxidase kit medical device manufacturer, bd, has issued a field safety notice concerning bbl dryslide pyr kit (catalogue number: 231747, lot number: 2276481) and bbl dryslide oxidase kit (catalogue number: 231746, lot number: 2222008). bd has confirmed through complaint investigation that during the manufacturing process portions of the test slides in the above referenced products were placed into the incorrect product packaging. this could result in intermittent quality control failures and false results. the manufacturer advises to discontinue and discard affected products and product replacement can be arranged. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 26 april 2013.

Device

BD BBL DrySlide PYR Kit and BD BBL DrySlide Oxidase Kit
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: BD BBL DrySlide PYR Kit and BD BBL DrySlide Oxidase Kit
  • Manufacturer
    BD

Manufacturer

BD