Synchron LX20 PRO Clinical Chemistry 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
    45960
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1095-2008
  • 사례 시작날짜
    2007-04-05
  • 사례 출판 날짜
    2008-05-24
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2013-01-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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) - Product Code JJE
  • 원인
    Intermittent failure of stirrer motor-beckman coulter has determined that incorrect glucose results on lx20 or dxc instruments have been related to an intermittent failure of the stirrer motor. -stirrer motors can stall without any flags or motion errors. -if a stall occurs during a glum test near the time of sample inject, results may be affected. -affected glum results may be high or low.
  • 조치
    GLUm stir motors greater than one year old were replaced. Replacements began April 5, 2007. Based on the Risk Assessment, BCI decided that Customer Notification is not needed. GLUm stir motors greater than one year old will be replaced on high volume LX/DxC systems by 3rd quarter of 2007. Replacements began April 5, 2007. A new stirrer design is being developed and is expected to be available before 4th quarter of 2007. Implementation Strategy of Stock Control: 1. A Stop Ship was not necessary based on risk assessment. The possibility of stirrer motor failure may increase with time and duty cycles. Systems running a high volume of tests may have a greater likelihood of exhibiting stirrer motor failure with motors greater than one year old. 2. New Customers were placed on a preventative maintenance plan to have their motor replaced at one year cycle. Completed 3. A Technical Update was issued to notify Hotline and Field Service Personnel of the issues.

Device

  • 모델명 / 제조번호(시리얼번호)
    Part Number: 476100. All serial numbers. All software versions.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including Canada.
  • 제품 설명
    Synchron LX20 PRO, Part Number 476100, Beckman Coulter, Inc.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Beckman Coulter Inc, 200 S Kraemer Blvd, Brea CA 92822-6208
  • Source
    USFDA