Events

Alerta De Seguridad para Vysis FISH Pretreatment Reagent Kits, Paraffin Pretreatment Reagent Kits & Protease Vials

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Abbott Molecular Incorporation.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2012-05-21
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120521a.html
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    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
  • Modelo / Serial
  • Descripción del producto
    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
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “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