Events

Device Recall Siemens ADVIA Centaur MultiDiluent 1 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Siemens Healthcare Diagnostics, Inc 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
    62702
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2313-2012
  • 사례 시작날짜
    2012-07-25
  • 사례 출판 날짜
    2012-09-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-11-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111446
  • 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
    Test,natriuretic peptide - Product Code NBC
  • 원인
    Decrease in onboard dilution recovery when using multi-diluent 1 that has been stored on board the advia centaur and advia centaur xp systems for for bnp and tsh3 ultra assays.
  • 조치
    Siemens sent an "URGENT DEVICE RECALL NOTICE" dated July 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Field Correction Effectiveness Check Response Form was included for customers to complete and return via fax to (302) 631-7597. Contact your local Sales Representative for questions regarding this notice.

Device

Device Recall Siemens ADVIA Centaur MultiDiluent 1
  • 모델명 / 제조번호(시리얼번호)
    Lot # Expiry Date 2 Pack 76129 22 JUN 2012  77542 22 JUN 2012  78696 22 JUN 2012  80828 26 SEP 2012  80857 26 SEP 2012  81441 26 SEP 2012  82189 26 SEP 2012  83647 26 SEP 2012  84772 26 SEP 2012  86037 13 JAN 2013  86783 13 JAN 2013  88712 13 JAN 2013  90056 13 JAN 2013  91002 13 JAN 2013  93126 13 JAN 2013  6 Pack 76102 22 JUN 2012  76432 22 JUN 2012  77075 22 JUN 2012  78264 22 JUN 2012  79037 22 JUN 2012  81006 26 SEP 2012  82539 26 SEP 2012  83321 26 SEP 2012  84123 26 SEP 2012  85795 13 JAN 2013  86698 13 JAN 2013  88318 13 JAN 2013  89286 13 JAN 2013  90490 13 JAN 2013  91672 13 JAN 2013  93129 13 JAN 2013
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) and the countries of Canada, Argentina, Australia, Brazil, Chile, China, Croatia, Denmark, Ecuduar, Egypt,Guatemala, Hong Kong,India,Ireland, Israel,India, Japan,Korea, Mexico, Malyasia, Peru, Pakistan, Saudi Arabia,Singapore, Thailand,Uruguay, Viet Nam, and South Africa.
  • 제품 설명
    Siemens ADVIA Centaur Multi-Diluent 1 - Used for automated dilutions for the ADVIA Centaur BNP and TSH3 Ultra assays when on-board the ADVIA Centaur or ADVIA Centaur XP systems. || Catalog Numbers: || 2 Pack REF 07907174 (110312) || 6 Pack REF 07293184 (110313). || Used for automated dilutions for the ADVIA Centaur BNP and TSH3 Ultra assays when on-board the ADVIA Centaur or ADVIA Centaur XP systems.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc

Manufacturer

Siemens Healthcare Diagnostics, Inc
  • 제조사 주소
    Siemens Healthcare Diagnostics, Inc, 333 Coney St, East Walpole MA 02032-1516
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA