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-2127-2015
  • 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: 2470-0100 (51 units) DG01130134 DG02130152 DG03130216 DG03130255 DG04130263 DG04130279 DG04130289 DG04130328 DG05129261 DG06106456 DG06129310 DG08129556 DG10129701 DG10129780 DG11129850 DG11129872 DG12118702 DG12120031 DG12129891 SGWZ02140093 SGWZ02140094 SGWZ03140098 SGWZ03140099 SGWZ03140100 SGWZ05140104 SGWZ06150243 SGWZ07150244 SGWZ09150248 SGWZ10150252 SGWZ11150255 SGWZ12130001 SGWZ16140132 SGWZ17140137 SGWZ19140144 SGWZ20140148 SGWZ21130009 SGWZ21140151 SGWZ24130019 SGWZ27130021 SGWZ27140166 SGWZ29140171 SGWZ31140175 SGWZ34130035 SGWZ36130038 SGWZ37140196 SGWZ45130061 SGWZ45130067 SGWZ48140219 SGWZ49140222 SGWZ50130086 SGWZ52130091  Model: 3470-0100 (3 units)  DG11129817, SGWZ21130010,SGWZ27140163
  • 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, 550 samples || Product Code: 2470-0100, 3470-0100 || 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