Events

Retiro De Equipo (Recall) de Device Recall Oncomine Dx Target Test

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
    79649
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1480-2018
  • Fecha de inicio del evento
    2018-02-08
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162895
  • 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
    Next generation sequencing oncology panel, somatic or germline variant detection system - Product Code PQP
  • Causa
    The lower concentration of the rna panel could cause a no call or false negative for the reporting of ros1 fusion. if a physician relies on a false negative result, crizotinib could be improperly excluded from the patient's treatment regimen.
  • Acción
    The firm issued an Urgent: Medical Device Recall Notification, dated February 16, 2018, via e-mail and phone call to affected consignees. The letter identified the affected device and advised customers of the potential "No Call" or false positive outcomes. Users were advised that they may need an alternate method to determine the presence of ROS1 variant in previously tested patient samples, and that any future tests using the affected lot cannot be considered valid if "No Call" or "Negative" is the result. Requested action included reviewing previous results which used the affected lot. Customers are to complete the Customer Response Sheet provided and e-mail a scanned copy along with the letter to vineet.bansal1@thermofisher.com. Questions and comments should be directed to Vineet Bansal, 408-802-2341, vineet.bansal1@thermofisher.com.

Device

Device Recall Oncomine Dx Target Test
  • Modelo / Serial
    Lot 1705001 UDI: (01)10190302006385(17)180220(10)1705001(240)A32441
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Distributed to states: AZ, CA, NC, TX, and VA.
  • Descripción del producto
    Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). || A qualitative In Vitro Diagnostic test.
  • Manufacturer
    Life Technologies Corporation

Manufacturer

Life Technologies Corporation
  • Dirección del fabricante
    Life Technologies Corporation, 7335 Executive Way, Frederick MD 21704-8354
  • Empresa matriz del fabricante (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA