Device Recall Perkin Elmer 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Perkinelmer 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    71380
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2129-2015
  • 사례 시작날짜
    2015-06-03
  • 사례 출판 날짜
    2015-07-20
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2017-08-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    Counter (beta, gamma) for clinical use - Product Code JJJ
  • 원인
    Error in wizard2 barcode id label #023 content may produce erroneous results.
  • 조치
    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

  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: Model: 2470-0200 (13 units DG05129229 DG07118106 DG10129753 SGWZ01150228 SGWZ03140101 SGWZ03150234 SGWZ11140118 SGWZ21130011 SGWZ21130012 SGWZ28130023 SGWZ34140184 SGWZ34140185 SGWZ36130040 Model: 3470-0200 (5 units)  DG08129543, DG11129863, SGWZ06150240,SGWZ30130027, SGWZ31130028
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    Perkin Elmer WIZARD2 10-detector, 1000 samples || Product Code: 2470-0200, 3470-0200 || The Wizard¿" gamma counter is intended to detect and count gamma radiation emitted by clinical samples.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Perkinelmer, 940 Winter Street, Waltham MA 02451
  • 제조사 모회사 (2017)
  • Source
    USFDA