Events

UniCel DxC Synchron Clinical Systems and UniCel DxC Synchron Access Integrated Clinical Systems 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Beckman Coulter 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
    74569
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2272-2016
  • 사례 시작날짜
    2014-04-22
  • 사례 출판 날짜
    2016-07-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-02-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147928
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • 원인
    Possible leaking of no foam solution from the no foam bottle assembly on the unicel dxc synchron systems.
  • 조치
    An Important Product Notice dated 4/22/14 was sent to all their customers to inform them that Beckman Coulter has identified a manufacturing issue with a plastic fitting on the No Foam Bottle Assembly which may crack and cause No Foam solution to leak. The letter informs the customers of the impact, action to be taken, and resolution. Customers are asked to inspect the No Foam Bottle Assembly for leaks prior to refilling the bottle. If leaks occur, customers should contact Customer Support Center following the instructions provided. Customers are instructed to complete the enclosed response form within 10 days. Customers with questions are instructed to contact the firm's Customer Support Center - Via our website, http://www.beckmancoulter.com/customersupport/support - Via phone, call 1-800-854-3633 in the United States and Canada - Outside the United States and Canada, contact your local Beckman Coulter Representative.

Device

UniCel DxC Synchron Clinical Systems and UniCel DxC Synchron Access Integrated Clinical Systems
  • 모델명 / 제조번호(시리얼번호)
    Up to and including 6133
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- United Arab Emirates, Angola, Australia, Belgium, Bulgaria, Canada, Switzerland, China, Colombia, Costa Rica , Czech Republic, Germany, Denmark, Egypt, Eritrea, Spain, Finland, France, United Kingdom, Greece, Guatemala, Hong Kong, Indonesia, Ireland, India, Italy, Jordan, Japan, Korea, Republic of, Kuwait, Lebanon, Lithuania, Morocco, Mexico, Malaysia, Namibia, Netherlands, Norway, New Zealand, Oman, Panama, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, Romania, Serbia, Russian Federation, Rwanda, Saudi Arabia, Sweden, Singapore, Slovakia, Swaziland, Thailand, Tunisia, Turkey, Taiwan, US (including Puerto Rico), Vietnam, South Africa, and Zimbabwe.
  • 제품 설명
    UniCel DxC Synchron Clinical Systems and UniCel DxC Synchron Access Integrated Clinical Systems || The affected part is Part number 70300. Part number 970300 is used to transfer No Foam Solution from the No Foam Bottle to the Waste B canister and the Waste Manifold on the DxC Hydro System. || Catalog No. || UniCel DxC 800 Synchron Clinical Systems || UniCel DxC 600 Synchron Clinical Systems || UniCel DxC 600i Synchron Access Integrated Clinical Systems || UniCel DxC 880i Synchron Access Integrated Clinical Systems || UniCel DxC 660i Synchron Access Integrated Clinical Systems || Product Labeling Reference No. A93719 || For the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries.
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • 제조사 주소
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • 제조사 모회사 (2017)
    Danaher Corporation
  • Source
    USFDA