Events

Retiro De Equipo (Recall) de Device Recall SPOTLight" HER2 CISH 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 Life Technologies Corporation.

¿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
    60542
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0461-2012
  • Fecha de inicio del evento
    2011-11-14
  • Fecha de publicación del evento
    2012-01-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-02-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105719
  • 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
    In vitro diagnostic reagent may be contaminated with a fungal contaminant.
  • Acción
    Life Technologies sent an URGENT DEVICE RECALL letter dated November 14, 2011 by mail to all affected customers. The letter identified the product, description of problem, and actions to be taken by the user. Customers were instructed to examine inventory immediately, discontinue use, quarantine the material and return remaining inventory. Customers were advised to complete the Customer Response Sheet included for recovering inventory data and fax back to (+1) 716-774-6727 Technical Support or e-mail to techsupport@lifetech.com. Customers who had distributed the affected kits outside of their facility were instructed to immediately notify their customers of the recall. For questions call Technical Support, at (+1) 800-955-6288 opt. 2 then opt. 3.

Device

Device Recall SPOTLight" HER2 CISH Kit
  • Modelo / Serial
    Lot 1029335, Exp. August 31, 2012
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) in the states of CA and NV and the countries of: Canada, Venezuela, and the UK.
  • Descripción del producto
    SPOT-Light" HER2 CISH¿ Kit, catalog #84-0150, 20 tests/kit, labeled in part ***Invitrogen Corporation 7335 Executive Way Frederick MD 21704 www.invitrogen.com*** || Product Usage: The SPOT-Light HER2 CISH Kit is intended to quantitatively determine HER2 gene amplification in formalin-fixed, paraffin-embedded (FFPE) breast carcinoma tissue sections and is indicated as an aid in the assessment of patients for whom Herceptin¿ (trastuzumab) treatment is being considered.
  • Manufacturer
    Life Technologies Corporation

Manufacturer

Life Technologies Corporation
  • Dirección del fabricante
    Life Technologies Corporation, 7305 Executive Way, Frederick MD 21704-8354
  • Empresa matriz del fabricante (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA