Events

Retiro De Equipo (Recall) de Device Recall Roche Molecular Systems

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 Roche Molecular Systems, 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
    73703
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1830-2016
  • Fecha de inicio del evento
    2016-03-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-12-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144781
  • 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
    Somatic gene mutation detection system - Product Code OWD
  • Causa
    An error was found within the hungarian translations of the cobas¿ egfr mutation test v2 instructions for use (m/n 07340761001-01hu, doc rev. 1.0, dated 08/2015) and the cobas¿ cfdna sample preparation kit instructions for use (m/n 07573758001-01hu, doc. rev. 1.0, dated 05/2015).
  • Acción
    Roche Molecular Diagnostics Inc. issued an Urgent Field Safety Notice dated March 15, 2016 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Actions to be taken by the customer: " If you have utilized 2 ¿L of DNA PBB during testing of plasma specimens, the samples must be retested using the correct volume (2mL DNA PBB). Communication of this Field Safety Corrective Action This notice must be passed on to all those who need to be aware within your organization or to any organization/individual where the potentially affected devices have been distributed/supplied. Please maintain awareness of this notice and resulting action for an appropriate period to ensure the effectiveness of the corrective action. The undersigned confirms that this notice has been notified to the appropriate Regulatory Agency. For questions regarding this recall call 908-253-7200.

Device

Device Recall Roche Molecular Systems
  • Modelo / Serial
    EGFR v2: 07248563190 cfDNA: 07247737190
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Hungary
  • Descripción del producto
    cobas¿ EGFR Mutation Test, v2 and cobas¿ cfDNA Sample || Preparation Hungarian Translation Instructions for Use
  • Manufacturer
    Roche Molecular Systems, Inc.

Manufacturer

Roche Molecular Systems, Inc.
  • Dirección del fabricante
    Roche Molecular Systems, Inc., 1080 US Highway 202 S, Branchburg NJ 08876-3733
  • Empresa matriz del fabricante (2017)
    Roche Holding AG
  • Source
    USFDA