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-0634-2016
  • 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=142253
  • 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
    Model: 2470-0050 Serial Numbers: DG05106329 DG02117493 DG11107166 DG09106782 DG07118133 DG07118141 DG09106791 DG04117727 DG06118036 DG12107192 DG02106101 DG04106223 DG01128843 DG12107272 DG07118124 DG09106892 DG12118684 DG12118673 DG11107126 DG04117704 DG04117763 DG01117363 DG06106484 DG12107240 DG01128871 DG05117880 DG12118685 DG09118357 DG03106204 DG05106386 DG11107137 DG03106172 DG03106206 DG02106113 DG09106818 DG02106065 DG04106309 DG09106882 DG11118590 DG06106483 DG01117316 DG08118221 DG06117898 DG12107263 DG08118250 DG12118711 DG04117710 DG06106448 DG06106453 DG06106463 DG06117912 DG03106135 DG01117373 DG05117837 DG06106517 DG01128805 DG06117970 DG04106310 DG02117521 DG06106538 Model: 3470-0050 (2 units) Serial Numbers: DG12118660 DG10118464
  • 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 ClWIZARD2 5-detector, 550 samples || Product Code: 2470-0050, 3470-0050. || The Wizard2 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