Events

Retiro De Equipo (Recall) de QMS Everolimus Assay

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 Microgenics 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
    74982
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0008-2017
  • Fecha de inicio del evento
    2016-08-15
  • Fecha de publicación del evento
    2016-10-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-01-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148982
  • 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
    Everolimus immunoassay - Product Code OUF
  • Causa
    A reagent stability issue (still under investigation) causes less separation in the calibration curve, which affects results across the entire range. for controls, maximum bias of +/- 35% for low levels, +/- 33% for mid-range levels, and +/- 47% for high levels is observed. bias in patient samples ranges from -15.7% to +5.2% with an average bias of -5.6% when comparing the qms everolimus assay to an everolimus lc-ms reference method. patient samples across the measuring range  sub-therapeutic, therapeutic, and supra-therapeutic  could be affected.
  • Acción
    Thermo Fisher sent an Urgent Medical Device Field Action letter dated on August 15, 2016 to customers via regular mail. The letter identified the affected product, problem and actions to be taken. Customers are advised to Discontinue use and destroy any remaining inventory of the affected lots per your local waste ordinances. Customers were instructed to cmplete the attached Medical Device Field Action Response Form and return the form to Thermo Fisher Scientific Technical Service. For questions contact Technical Service at 1-800-232-3342 (USA only) or 510-979-5000 (outside the USA) then press option 2, then option 3.

Device

QMS Everolimus Assay
  • Modelo / Serial
    Lot number: 72258049, Expiry date: 07/31/2017; Lot number: 72258007, Expiry date 07/31/2017.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in the states of KY, CA, NY, DC, NC, TX, IL, OH, IL, FL, IK, IA, MS and countries of Mexico, Taiwan, Guatemala, Malaysia, Argentina, Dominican Republic, Philippines, Germany, Australia.
  • Descripción del producto
    Thermo Scientific QMS Everolimus Assay; || Model number: || 0380000 (US Distribution); || 0373852 (Foreign Distribution) || Product Usage: || The QMS Everolimus Assay is intended for the quantitative determination of Everolimus, in human whole blood on automated clinical chemistry analyzers. The results obtained are used as an aid in the management of kidney and liver transplant patients receiving Everolimus therapy. This in vitro diagnostic device is intended for clinical laboratory use only. The QMS Everolimus assay is intended to be used as an aid in the management of patients receiving everolimus therapy for those organ transplant procedures indicated in the chart for each specific country.
  • Manufacturer
    Microgenics Corporation

Manufacturer

Microgenics Corporation
  • Dirección del fabricante
    Microgenics Corporation, 46500 Kato Rd, Fremont CA 94538-7310
  • Empresa matriz del fabricante (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA