Events

Device Recall BCS System 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
    73099
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0824-2016
  • 사례 시작날짜
    2016-01-14
  • 사례 출판 날짜
    2016-02-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-03-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143066
  • 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
    System, multipurpose for in vitro coagulation studies - Product Code JPA
  • 원인
    False short clotting times for pt on bcs and bcs xp with dade innovin can occur. this has also an effect for false low pt inr values. these false short clotting times were observed only with turbid, hemolytic and/or icteric samples from intensive care patients. the corresponding reaction curves of these samples showed a pre-peak, which can lead to falsely short clotting time. the result was not flagged by the existing check algorithms.
  • 조치
    Urgent Medical Device Correction Letter (dated 1/12/2016) was sent to US consignees via FedEx on 1/14/2016 and to foreign consignees (distribution is determined at country level). The letter re-emphasizes the importance of checking the interference levels given in the respective Application Sheets of the BCS and BCS XP systems. For questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative.

Device

Device Recall BCS System
  • 모델명 / 제조번호(시리얼번호)
    All serial numbers
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-US (nationwide) and the countries of Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bosnia Herzegovina, Brazil, Canada, Chile, China, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Guadeloupe, Hungary, Italy, Kuwait, Latvia, Lebanon, Libya, Macedonia, Mexico, Montenegro, Netherlands, Peru, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and Uruguay.
  • 제품 설명
    BCS Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10454728 (BCS RECONDITIONED), 10454729 (BCS RECONDITIONED), 10454742 (BEHRING COAGULATION SYSTEM), 10459303 (BCS RECONDITIONED), 10460659 (BCS INSTRUMENT), 10461881 (BCS INSTRUMENT), IVD --- Device Listing D018966
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • 제조사 주소
    Siemens Healthcare Diagnostics, Inc., 511 Benedict Ave, Tarrytown NY 10591-5005
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA