Events

Alerte De Sécurité sur Vysis FISH Pretreatment Reagent Kits, Paraffin Pretreatment Reagent Kits & Protease Vials

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 Incorporation.

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
    2012-05-21
  • 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_20120521a.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: abbott molecular vysis fish pretreatment reagent kits, paraffin pretreatment reagent kits & protease vials medical device manufacturer, abbott molecular incorporation, has issued an field advisory notice concerning the vysis fish pretreatment reagent kit, [list number 02j03-032]; vysis paraffin pretreatment reagent kit, [list number 02j02-032]; paraffin pretreatment reagent kit ii, [list number 07j02-002]; protease i, 250mg x 2 vials, [list number 02j08-032] respectively. the manufacturer identified protease vials that were under filled and over filled. this may result in under or over digestion of the specimens and controls. according to the manufacturer, under or over digestion of specimens or controls could cause fish assays to be difficult to interpret or produce invalid/uninformative results. an invalid/uninformative control slide or specimen slide would result in the need to perform a repeat analysis with fresh control slides and specimen slide(s). there is no impact on results generated for slides that produce valid and interpretable results. according to the local supplier, the affected devices were distributed in hong kong. for details, please refer to the attached field advisory notice. if you are in possession of the product, please contact your supplier for necessary actions.

Device

Vysis FISH Pretreatment Reagent Kits, Paraffin Pretreatment Reagent Kits & Protease Vials
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Abbott Molecular Vysis FISH Pretreatment Reagent Kits, Paraffin Pretreatment Reagent Kits & Protease Vials
  • Manufacturer
    Abbott Molecular Incorporation

Manufacturer

Abbott Molecular Incorporation
  • 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