Events

Retiro De Equipo (Recall) de Device Recall Tecan Infinite M1000

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 Tecan US, 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
    74806
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2664-2016
  • Fecha de inicio del evento
    2016-07-25
  • Fecha de publicación del evento
    2016-08-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-01-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148497
  • 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
    Colorimeter, photometer, spectrophotometer for clinical use - Product Code JJQ
  • Causa
    The batteries have the potential to overheating, melt or char.
  • Acción
    Tecan contacted all customers by Safety Announcement, via certified mail starting July 25, 2016. The letter identified the product, the problem, and the action to be taken by the customer. Because affected batteries pose a fire and burn hazard, it is extremely important that customers check whether their battery is affected. Customers were advised to go immediately to the HP Battery Recall website at: http://www.HP.com/go/batteryprogram2016 to check if their battery is affected by this recall. Customers were also advised to complete and return the Customer Response Form at QA@tecan.com or fax it to 919-287-2961. Customers with questions should contact HP at 1-888-202-4320 or Tecan Technical Service's Helpdesk at 800-832-2687, option 1.

Device

Device Recall Tecan Infinite M1000
  • Modelo / Serial
    Instrument Material #30034301, PC Serial number: 2CE33625NS, Instrument Serial #1508007738.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US including AK, AL, AR, CA, FL, GA, HI, KY, MA, MD, NC, NY, PA, PR, SC, TN, TX, UT, VA. International account: Canada.
  • Descripción del producto
    Tecan Infinite M1000 || The Tecan Infinite M1000 is a multifunctional monochromator based microplate reader that provides high performance for the vast majority of todays microplate applications and research. Besides offering absorbance and fluorescence intensity measurements, the Infinite M1000 allows the measurement of fluorescence polarization and luminescence. The Infinite M1000 is also robotic compatible and offers a built-in stacker option as well as an external injector module. The Infinite M1000 is intended as a general purpose laboratory instrument for professional use, supporting common microplates conforming to the ANSI/SBS standards
  • Manufacturer
    Tecan US, Inc.

Manufacturer

Tecan US, Inc.
  • Dirección del fabricante
    Tecan US, Inc., 9401 Globe Center Drive, Suite 140, Morrisville NC 27560
  • Empresa matriz del fabricante (2017)
    Tecan Group AG
  • Source
    USFDA