Events

Retiro De Equipo (Recall) de Device Recall Dako HER2 CISH pharmDx Kit

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Dako North America Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    74408
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2099-2016
  • Fecha de inicio del evento
    2016-06-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-09-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147442
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Chromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer - Product Code NYQ
  • Causa
    An incorrect her2 probe concentration was used when producing the probe component (vial 3) in this kit lot. this has resulted in the her2 probe concentration being too low.
  • Acción
    Dako sent a recall notification dated June 10, 2016 to all customers. The letter identified the affected product, problem, the investigation findings, the affected results, and the actions to be taken. Customers are instructed to complete and return the enclosed device recall form to Dako QA Vigilance by Dako.dkvigilance@agilent.com. Customers with questions regarding the notification, are instructed to contact their sales representative.

Device

Device Recall Dako HER2 CISH pharmDx Kit
  • Modelo / Serial
    20031683
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in the states of: PA, CA, AL, NC and countries of Austria, Bosnia and Herzegovina, Belgium, Bulgaria, Brazil, Canada, Switzerland, Germany, Spain, France, Greece, Italy, Macedonia, Qatar, Romania, Serbia, Sweden, and Turkey.
  • Descripción del producto
    Dako HER2 CISH pharmDx Kit, product code: SK 109 || Product Usage: || For in vitro diagnostic use. HER2 CISH pharmDx Kit is intended for dualcolor chromogenic visualization of signals achieved with directly labeled in situ hybridization probes targeting the HER2 gene and centromeric region of chromosome 17. The kit is designed to quantitatively determine HER2 gene status in formalin-fixed, paraffin-embedded breast cancer tissue specimens. Red and blue chromogenic signals are generated on the same tissue section for evaluation under bright field microscopy. The CISH procedure is automated using Dako Autostainer instruments. HER2 CISH pharmDx Kit is indicated as an aid in the assessment of patients for whom Herceptin (trastuzumab) treatment is being considered. Results from the HER2 CISH pharmDx Kit are intended for use as an adjunct to the clinicopathologic information currently used for estimating prognosis in stage II, node-positive breast cancer patients.
  • Manufacturer
    Dako North America Inc.

Manufacturer

Dako North America Inc.
  • Dirección del fabricante
    Dako North America Inc., 1170 Mark Ave, Carpinteria CA 93013-2918
  • Source
    USFDA