Events

Alerta De Seguridad O Notificaciones De Seguridad para Roche Tissue Diagnostics (Ventana Medical Systems)

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por Roche Tissue Diagnostics.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert / Field Safety Notice
  • Fecha
    2018-02-15
  • Fecha de publicación del evento
    2018-02-15
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://www.gov.uk//drug-device-alerts/roche-tissue-diagnostics-ventana-medical-systems-optiview-dab-ihc-detection-kit-ultraview-universal-dab-detection-kit-optiview-amplification-kit-and-hematoxylin-ii-dispenser-failure-of-hematoxylin-ii-and-horseradish-peroxidase-rea
  • Notas / Alertas
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 recall data from the U.S. and the United Kingdom.
  • Notas adicionales en la data
    The manufacturer has informed the MHRA of increased customer complaints reporting leaking and sticking of the reagent dispenser, which could result in the failure of a reagent critical to the staining reaction (light or absent staining).These devices are used to detect markers in a range of pathological conditions including those associated with cancer (e.g. HER2,ER/PR, ALK and PD-L1).As a consequence, there is a risk of false negative results (e.g. with all companion diagnostics such as HER2 tests) affecting clinical decisions for patients, due to commence treatment.
  • Causa
    Roche tissue diagnostics (ventana medical systems) – leaking and sticking reagent dispensers may cause weak staining on tissue samples, which may lead to false negatives and misdiagnosis.
  • Acción
    Ensure all relevant members of staff receive the manufacturer’s Field Safety Notice, and that they understand the problem and the actions to be taken. Affected lots may only be used if same slide controls are used. Users who do not use same slide controls should not use affected lots, and are advised to destroy affected kits, and request replacement kits from the manufacturer. The use of appropriate same slide controls is highly recommended as it helps ensure the efficacy of all Immunohistochemistry (IHC) assays carried out on every slide on an automated IHC instrument. Consider the need to review previous test results obtained using affected lots. If any adverse event occurs relating to this issue, please report this to MHRA via Yellow Card or the relevant devolved administrations (Scotland, Wales and Northern Ireland).

Device

Roche Tissue Diagnostics (Ventana Medical Systems)
  • Modelo / Serial
  • Descripción del producto
    Dispenser issues with Hematoxylin II and Horseradish Peroxide Reagents which are used in the following kits:Product Name Roche DMS Lots OptiView DAB IHC Detection Kit 06396500001 Y19271, Y11625, Y15571 OptiView Amplification Kit 06396518001 Y15435, Y19322, Y22447 UltraView Universal DAB Detection Kit 05269806001 Y09284, Y15384, Y18099, Y22153, Y11687, Y17984, Y19302, Y11716, Y18069 Hematoxylin II 05277965001 Y10759, Y17402, Y21312, Y13938, Y17403
  • Manufacturer
    Roche Tissue Diagnostics

Manufacturer

Roche Tissue Diagnostics
  • Dirección del fabricante
    Roche Diagnostics Ltd Charles Avenue Burgess Hill West Sussex RH15 9RYRegistration Number: 571546Technical Support Hotline (UK): 08081 001 920Email: emea.tcceurope@roche.com
  • Empresa matriz del fabricante (2017)
    Roche Holding Ag
  • Source
    MHRA