Events

Retiro De Equipo (Recall) de Device Recall AB Sciex API 3200MD, 3200MD QTRAP, Triple Quad, QTRAP 4500MD LC/MS/MS 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 Ab Sciex.

¿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
    73433
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1586-2016
  • Fecha de inicio del evento
    2016-02-24
  • Fecha de publicación del evento
    2016-04-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-02-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144196
  • 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
    Mass spectrometer, clinical use - Product Code DOP
  • Causa
    Wrong quantitative results may be displayed in a report from the device, which may potentially lead to an incorrect patient diagnosis.
  • Acción
    Sciex sent an Urgent Medical Device Correction letter dated February 29, 2016, to all affected US customers via Fedex on March 2, 2016. International customers were notified beginning on March 3, 2016. The letter informed customers of the issue and requests that they take temporary steps to eliminate the potential for erroneous events. In addition, a software update is in development and is expected to be available in approximately 4 weeks. Customers with questions were instructed to contact SCIEX at 1-289-982-2531.

Device

Device Recall AB Sciex API 3200MD, 3200MD QTRAP, Triple Quad, QTRAP 4500MD LC/MS/MS Systems
  • Modelo / Serial
    Software Versions: Version 1.6.1 and 1.6.2
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (Nationwide) and Internationally to the following countries: AUSTRIA CANADA CHINA FRANCE GERMANY INDIA IRELAND ITALY KOREA MALAYSIA NETHERLANDS NORWAY RUSSIA SINGAPORE SPAIN SWITZERLAND UNITED KINGDOM
  • Descripción del producto
    Analyst¿ MD Version 1.6.1 and 1.6.2 Software used with the following instruments: API 3200MD" LC/MS/MS System, Instrument Part Number: 5024501; 3200MD QTRAP¿ LC/MS/MS System, Instrument Part Number: 5024500; Triple Quad" 4500MD LC/MS/MS System, Instrument Part Number: 5031257; QTRAP¿ 4500MD LC/MS/MS System, Instrument Part Number: 5031231 || 3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compound under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass. It is intended for in vitro diagnostic purposes. For in vitro diagnostic use.
  • Manufacturer
    Ab Sciex

Manufacturer

Ab Sciex
  • Dirección del fabricante
    Ab Sciex, 500 Old Connecticut Path, Framingham MA 01701-4574
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    USFDA