Events

Device Recall UniCel DxC Synchron Clinical System 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
    54344
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-0863-2010
  • 사례 시작날짜
    2010-01-04
  • 사례 출판 날짜
    2010-03-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-04-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88235
  • 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
    Chemistry Analyzer (Discrete Photometric) for Clinical Use - Product Code JJE
  • 원인
    Excessive buildup of protein, bacteria and sample tube additives in the ise flow cell may cause erroneous na (sodium) results.
  • 조치
    An Urgent: Product Corrective Action letter dated January 4, 2010, was mailed to customers advising of erroneous sodium results derived from build up of protein, bacteria and additives in the ISE flow cell. The letter discussed the impact and actions to be taken along with some additional recommendations. Customers are advised to follow the new maintenance instructions included with the letter. The information in the letter should be shared with laboratory staff and the notification should be retained as part of the Quality System documentation. A copy of the letter should be provided to any other laboratory that affected product was forwarded to. The enclosed response form should be completed and returned. Questions should be directed to the Customer Support Center at 1-800-854-3633.

Device

Device Recall UniCel DxC Synchron Clinical System
  • 모델명 / 제조번호(시리얼번호)
    All serial numbers. PN Numbers: A10405 (UniCel DxC 600); A11810 (UniCel DxC 600 PRO); A27318 (UniCel DxC 600i); A11816 (UniCel DxC 800); A11812 (UniCel DxC 800 PRO); A59102 (UniCel DxC 880i); A64903 (UniCel DxC 680i); A64871 (UniCel DxC 660i); A64871 (UniCel DxC 860i); and A64935 (UniCel DxC 860i).
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA and Canada.
  • 제품 설명
    Beckman Coulter UniCel DxC Synchron Clinical System ISE Flow Cell. || PN Numbers: A10405 (UniCel DxC 600); A11810 (UniCel DxC 600 PRO); A27318 (UniCel DxC 600i); A11816 (UniCel DxC 800); A11812 (UniCel DxC 800 PRO); A59102 (UniCel DxC 880i); A64903 (UniCel DxC 680i); A64871 (UniCel DxC 660i); A64871 (UniCel DxC 860i). || Intended for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries of clinical interest in biological fluids such as serum, plasma, urine, or cerebrospinal fluid.
  • 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