Events

Retiro De Equipo (Recall) de Device Recall Perkin Elmer

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.

¿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
    72808
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0632-2016
  • Fecha de inicio del evento
    2015-12-08
  • Fecha de publicación del evento
    2016-01-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-08-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142251
  • 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
    Counter (beta, gamma) for clinical use - Product Code JJJ
  • Causa
    The content of the second #023 barcode id label in the barcode id label binder is incorrect. the second barcode id label #023 symbol incorrectly identifies as #024 when scanned. if measurement protocols have been programmed for both id #023 and #024, the protocol associated with barcode id #024 is executed. if the error is undetected, the gamma counter may produce erroneous results.
  • Acción
    Perkin Elmer sent an Urgent Medical Device Correction letter dated December 7, 2015 to affected customers. The letter identified the affected products, problems and actions to be taken. Customers were instructed to destroy all affected products in their possession. Customers were asked to complete the enclosed Correction Response Form and return it by scan and e-mail to QMresponse.SG@perkinelmer.com . Corrected barcode labels ID #023 will be provided upon request and return of the completed Correction Response Form to PerkinElmer. For further information contact your local PerkinElmer representatives..

Device

Device Recall Perkin Elmer
  • Modelo / Serial
    Serial Numbers: DG06106539 DG12118720 DG07106646 DG12107250 DG12107281 DG03117619 DG11118605 DG01117400 DG12107202 DG01117401 DG06106449 DG03117666 DG05117791 DG06106454 DG03106180 DG11118637 DG07118121 DG07106598 DG11118633 DG06106520 DG03106137 DG07118111 DG02128888 DG08118247 DG06118014 DG01128790 DG12107207 DG07106637 DG01128876 DG04117764 DG01106035 DG12118780 DG05106342 DG01117399 DG06117909 DG06118011 DG09106846 DG11107146 DG12118694 DG08118217 DG02106084 DG04117690 DG05117838 DG09106799 DG04117735 DG03117548 DG01117362
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHINA, DENMARK, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, GREECE, HONG KONG, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, MYANMAR, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, and THAILAND.
  • Descripción del producto
    Perkin Elmer WIZARD2 1-detector, 550 samples Product Code: 2470-0010 || The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples
  • Manufacturer
    Perkinelmer

Manufacturer

Perkinelmer
  • Dirección del fabricante
    Perkinelmer, 940 Winter Street, Waltham MA 02451
  • Empresa matriz del fabricante (2017)
    Perkin Elmer Inc.
  • Source
    USFDA