Events

Rappel de Device Recall Perkin Elmer

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Perkinelmer.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    72808
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0633-2016
  • Date de mise en oeuvre de l'événement
    2015-12-08
  • Date de publication de l'événement
    2016-01-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-08-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142252
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Counter (beta, gamma) for clinical use - Product Code JJJ
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    Serial Numbers: DG02117524 DG09118363 DG08118156 DG08118195 DG02128922 DG10118375 DG12107235 DG08118222 DG02117537 DG08118184 DG09106872 DG11107116 DG03117626 DG03117611 DG01117425 DG12107293 DG09118332 DG06106503 DG06118006 DG01128820 DG12118707 DG05106427 DG03106166 DG11118630 DG01117434 DG09106779 DG02117500 DG12118742 DG06106477 DG03106208 DG09106800 DG10106903 DG05117853 DG03117671 DG06106473 DG04117754 DG04117698 DG11118538 DG11118617 DG01117392 DG03117644 DG05117882 DG03117655 DG04117683 DG02106106 DG05106347 DG06118043 DG10118385 DG08106671 DG01128869 DG06118023 DG05106328 DG02117516 DG11107142 DG05106354 DG08118254 DG03106181 DG03106197 DG02117505 DG11107105
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    Perkin Elmer WIZARD2 2-detector, 550 samples Product Code: 2470-0020 || The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples
  • Manufacturer
    Perkinelmer

Manufacturer

Perkinelmer
  • Adresse du fabricant
    Perkinelmer, 940 Winter Street, Waltham MA 02451
  • Société-mère du fabricant (2017)
    Perkin Elmer Inc.
  • Source
    USFDA