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-2125-2015
  • 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: DG01130042 DG01130083 DG01130122 DG02130179 DG03130196 DG03130242 DG04130300 DG04130318 DG05129208 DG05129239 DG05129251 DG05130343 DG06129284 DG06129320 DG07129407 DG07129433 DG08118247 DG08129522 DG08129575 DG09129612 DG09129619 DG09129643 DG10129707 DG10129728 DG10129768 DG11129836 DG11129838 DG12120004 DG12120038 SGWZ03150235 SGWZ04140103 SGWZ07140107 SGWZ07140108 SGWZ14140125 SGWZ16140131 SGWZ16140134 SGWZ20140150 SGWZ21140152 SGWZ27130022 SGWZ28140168 SGWZ29130026 SGWZ32130030 SGWZ33140183 SGWZ35140188 SGWZ36130039 SGWZ37130044 SGWZ39130048 SGWZ42130051 SGWZ43130053 SGWZ43130056 SGWZ44130057 SGWZ45130062 SGWZ47130076
  • 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
    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

Manufacturer

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