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
    71380
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2130-2015
  • Date de mise en oeuvre de l'événement
    2015-06-03
  • Date de publication de l'événement
    2015-07-20
  • 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=137595
  • 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
    Error in wizard2 barcode id label #023 content may produce erroneous results.
  • Action
    Perkin Elmer issued the recall letter on June 3, 2015. Action to be taken: Until the PerkinElmer correction has been completed, we request you immediately destroy all barcode ID labels #023 in your possession. The WIZARD Gamma Counter barcode label binder contains a total of 20 barcode labels identified as #023 (i.e. 2 labels on each of 10 pages). Please ensure you remove the barcode labels ID #023 from all barcode label binders in your possession. Please be sure to inspect all sample racks to remove and destroy any barcode ID labels #023 already affixed to racks. A WIZARD2 Gamma Counter barcode label binder with corrected barcode labels ID #023 will be provided upon request and return of the completed Correction Response Form to PerkinElmer. Correction Response Form and return it by scan and e-mail to QMresponse.SG@perkinelmer.com

Device

Device Recall Perkin Elmer
  • Modèle / numéro de série
    Serial Numbers: DG01130076 DG01130081 DG01130107 DG01130113 DG02130148 DG02130157 DG02130171 DG02130172 DG02130174 DG02130176 DG03129032 DG03130218 DG03130220 DG03130223 DG03130225 DG03130227 DG03130240 DG03130247 DG04106271 DG04129101 DG04129141 DG04129168 DG05129187 DG05129210 DG05129256 DG05129258 DG06117938 DG06129274 DG06129282 DG06129289 DG06129333 DG06129336 DG06129341 DG06129343 DG06129345 DG06129346 DG06129354 DG07129436 DG07129444 DG07129445 DG07129446 DG07129448 DG07129449 DG08118168 DG08118169 DG08129491 DG08129502 DG08129505 DG08129506 DG08129544 DG08129545 DG08129595 DG09129607 DG09129622 DG09129623 DG09129644 DG10129700 DG10129708 DG10129717 DG10129726 DG10129759 DG10129763 DG10129777 DG10129784 DG11095721 DG11129816 DG11129823 DG11129839 DG11129854 DG12120039 DG12129887 DG12129893 DG12129902 DG12129903 DG12129904 DG12129905 DG12129931 DG12129932 SGWZ02140095 SGWZ02140096 SGWZ02140097 SGWZ02150231 SGWZ03150233 SGWZ04150236 SGWZ04150237 SGWZ07140106 SGWZ07150245 SGWZ08140109 SGWZ08140110 SGWZ08140111 SGWZ08150246 SGWZ09140112 SGWZ10140115 SGWZ10150250 SGWZ11150253 SGWZ12140120 SGWZ12140121 SGWZ12140122 SGWZ13140123 SGWZ13140124 SGWZ14130004 SGWZ15140127 SGWZ15140129 SGWZ17130005 SGWZ18140138 SGWZ19140142 SGWZ19140143 SGWZ20130008 SGWZ20140146 SGWZ20140149 SGWZ21140153 SGWZ22130013 SGWZ22130014 SGWZ22140155 SGWZ22140156 SGWZ23130015 SGWZ23140157 SGWZ24140158 SGWZ25130020 SGWZ27140162 SGWZ27140165 SGWZ28140167 SGWZ29140170 SGWZ30140172 SGWZ30140173 SGWZ31130029 SGWZ31140177 SGWZ31140178 SGWZ32130031 SGWZ32140181 SGWZ32140182 SGWZ33130032 SGWZ33130033 SGWZ34140186 SGWZ35130037 SGWZ35140187 SGWZ35140189 SGWZ36130041 SGWZ36140191 SGWZ36140194 SGWZ37130045 SGWZ37140195 SGWZ39130047 SGWZ39140197 SGWZ39140198 SGWZ40140199 SGWZ40140200 SGWZ41130049 SGWZ42130050 SGWZ42140201 SGWZ42140202 SGWZ42140203 SGWZ43130055 SGWZ44130059 SGWZ44130060 SGWZ44140210 SGWZ44140211 SGWZ45130064 SGWZ45130066 SGWZ45140212 SGWZ45140213 SGWZ45140214 SGWZ46130069 SGWZ46130070 SGWZ46130071 SGWZ46130072 SGWZ47130073 SGWZ47130074 SGWZ48140220 SGWZ48140221 SGWZ49130081 SGWZ49130082 SGWZ49130083 SGWZ49140223 SGWZ50130084 SGWZ51130089 SGWZ51130090 SGWZ51140224 SGWZ52140225
  • 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 BRAZIL CANADA CHILE CHINA COSTA RICA CROATIA CZECH REPUBLIC DENMARK ETHIOPIA FINLAND FRANCE GERMANY GREECE HONG KONG HUNGARY INDIA IRELAND ISRAEL ITALY JAPAN KOREA KUWAIT LUXEMBOURG MEXICO MYANMAR NETHERLANDS NORWAY PHILIPPINES POLAND REUNION SAUDIA ARABIA SINGAPORE SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND TURKEY UK.
  • Description du dispositif
    Perkin Elmer WIZARD2 1-detector,3", 1000 samples || Product Code: 2480-0010 || 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