Events

Device Recall Beckman Coulter UniCel DxC 880i, 860i, and 600i 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
    55173
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2590-2010
  • 사례 시작날짜
    2010-02-25
  • 사례 출판 날짜
    2010-09-30
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-07-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90219
  • 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
    Beckman coulter is initiating a recall on their unicel dxc clinical systems (880i, 860i,680i and 660i systems with serial number <2760 that have software version 4.9.01 installed and have the vme motorola ics board) because they may exhibit issues with stat sample rack loading, causing a possible delay in results.
  • 조치
    Beckman Coulter sent an URGENT: FIELD SAFETY NOTICE letter, dated March 25, 2010, to all customers. The letter identified the affected product, the problem, and the actions customers take. Customers were instructed to: if the UniCel DxC system serial number was less than 2760 the customer should contact their local representative to arrange for an upgrade to software version 4.9 build 02. Complete and return the enclosed response form within 10 days of the notice. Share the information with their laboratory staff and retain the notification as part of the Quality System documentation. If affected products were forwarded to another laboratory, provide a copy of the notification letter to them. Customers may contact the Customer Support Center (Hotline) at 1-800-854-3633. For questions or comments please contact the firm at (714) 961-3634

Device

Device Recall Beckman Coulter UniCel DxC 880i, 860i, and 600i Systems
  • 모델명 / 제조번호(시리얼번호)
    Software Part Number: A84500, A86646; Software version: 4.9.01; Serial Number <2760
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Class II Recall - USA, including the states of CA, IN, GA, NC, NY, OH, SC, and WI
  • 제품 설명
    UniCel DxC 880i, 860i and 600i Systems; Software Part Number: A84500, A86646; Software || version: 4.9.01 || The UniCel Synchron Clinical Systems are fully automated, computer-controlled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whole blood (sample type is chemistry dependent)
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • 제조사 주소
    Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
  • 제조사 모회사 (2017)
    Danaher Corporation
  • Source
    USFDA