Events

Retiro De Equipo (Recall) de Device Recall PantheraPuncher 9 .

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 PerkinElmer Health Sciences, 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
    68686
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2153-2014
  • Fecha de inicio del evento
    2014-07-01
  • Fecha de publicación del evento
    2014-08-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-10-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128446
  • 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
    Panthera-Puncher 9 . - Product Code ooo
  • Causa
    Risk of incorrect results from samples prepared with panthera-puncher 9.
  • Acción
    Perkin Elmer sent an Urgent Medical Device Recall letter dated July 1, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The Recall Letter delivered to the end customer by email facilitated through our Perkin Elmer Technical Support group located in Akron Ohio. Technical Support will be asked to make sure the customers receive the Recall Letter and implement the recommended precautions: "Removing the plates from the Panthera-Puncher 9 when not actively punching and processing samples in the instrument. "Opening the plate track hatch if plates must reside in the Panthera-Puncher 9 while the instrument is idle or in sleep mode. This will interrupt power to the ionizer and eliminate any ionizer impact on the plate wells. For further information, please contact your local Perkin Eimer representative or GSTechnicaiSupport@PerkinEimer.com. For further information please call (781) 663-6900.

Device

Device Recall PantheraPuncher 9 .
  • Modelo / Serial
    Serial Numbers: 20810001 through 20810148
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of : Canada, Australia, Brazil, China, Denmark, Great Britain, Italy, France, Mexico, Qatar and Korea.
  • Descripción del producto
    Panthera-Puncher 9 . || Panthera-Puncher 9 is a sample transfer instrument for professional use. The sample, a dried blood disk, is extracted from a larger area of the sample (dried blood spot) by punching the disk of the specified size to a sample collection vessel, e.g. a 96-well microtiter plate. The identification of the sample punched to a specific well of the plate is stored and carried on to the next instrument or the data is transferred to the LIMS.
  • Manufacturer
    PerkinElmer Health Sciences, Inc.

Manufacturer

PerkinElmer Health Sciences, Inc.
  • Dirección del fabricante
    PerkinElmer Health Sciences, Inc., 940 Winter St, Waltham MA 02451-1457
  • Empresa matriz del fabricante (2017)
    Perkin Elmer Inc.
  • Source
    USFDA