Events

AU2700 and AU5400 Clinical Chemistry Analyzers 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
    65118
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1430-2013
  • 사례 시작날짜
    2013-04-26
  • 사례 출판 날짜
    2013-05-29
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-08-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117918
  • 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 recalling au2700/au2700 plus & au5400 clinical chemistry analyzers becuase it was determined that the tubing/joint connections associated with these mods may leak concentrated detergent. beckman coulter has received complaints that the joint connecting the tubing appears to disintegrate over time, causing a leak.
  • 조치
    Beckman Coulter sent an Urgent Product Correction letter on April 26, 2013 along with a response form. The letter notified customers of the product, problem, and actions to be taken by the customers. Contact the Call Center at 800-854-3633 for questions regarding this notice.

Device

AU2700 and AU5400 Clinical Chemistry Analyzers
  • 모델명 / 제조번호(시리얼번호)
    All Serial Numbers  Model Numbers: AU2700, AU27000ISE, AU5421, AU5421ISE, AU5431.  Part Numbers: E0750053 N3663400  N3663700  N3664000  N3664200  N3664400  N3664600  N3664800  N3878500  1465600  64270G  E61DAU2700 N3663500  N3663600  N3663800  N3663900  N3664100  N3664300  N3664500  N3664700  N3664900  N3878600  O9102700 N3665000  N3665100  N3665200  N3665300  N3665400  N3878300  64542  A94504  N1683100  AU5431-U1  N3665500  N3665600  N3665700  N3665800  N3665900  N3878400
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA Nationwide and countries of: AU, CA, DE, ES, GB, IT, PT, and JP.
  • 제품 설명
    AU2700 Clinical Chemistry Analyzer || AU5400 Clinical Chemistry Analyzer || Perform automated analysis of serum, urine, and other body fluids, including whole blood.
  • 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