Events

Beckman Coulter AU400, AU640, AU2700, and AU5400 Clinical 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
    66253
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0152-2014
  • 사례 시작날짜
    2013-09-09
  • 사례 출판 날짜
    2013-11-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-09-30
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121891
  • 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
    The recall was initiated because beckman coulter has confirmed that some au clinical chemistry analyzer ise units can experience premature ise ref (reference) valve failure. premature valve failure can be detected by the presence of air bubbles in the ise ref solution tubing on the ise unit. if air bubbles are present, accuracy of the ise test results may be affected.
  • 조치
    A customer notification letter dated 9/9/13 was sent to customers who received the ISE REF Valve, Part Number MU3226 for the AU400, AU640, AU2700, AU5400 and the ISE REF Valve, Part Number MU7638 for the AU480, AU680, AU5800 Chemistry Analyzers. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions are instructed to contact Beckman Coulter Customer Support Center via http://www.beckmancoulter.com/customersupport/support, via phone at (800) 854-3633 in the US and Canada. Outside of the US and Canada, customers are instructed to contact their local Beckman Coulter Representative.

Device

Beckman Coulter AU400, AU640, AU2700, and AU5400 Clinical Analyzers
  • 모델명 / 제조번호(시리얼번호)
    AU400, Item Code: 5427200 5427400 5427600 N1254000 N1254200 N1254400 N1254600 N1255000 n1255200 N1257400 N2571700 N2571800 N3658500 N3658700 N3658800 N3659000 N3659400 N3912300 N9020723 N9020724   AU400 OPA, Item Code: 5427300 5427900 N1257700   AU640, Item Code: 5900100 5900400 5900600 N1255700 N1255900 N1256100 N1256300 N1256700 N2572800 N3660900 N3661200 N3661300 N3661500 N3661700 N3661900  AU640 OPA, Item Code: 590220 5902400 A92928 A92929  AU2700, Item Code: 5996300 5996500 5998100 N1465100 N1465300 N1465500 N1465600 N1465900 N1466100 N1815200 N1815600 N1815700 N1816200 N1816300 N3155800 N3155900 N3156000 N3156100 N3156200 N3156300 N3156400 N3156500 N3156600 N3156800 N3157000 N3663100 N3663300 N3663500 N3663600 N3663800 N3663900 N3664100 N3664300 N3664500 N3664700 N3664900 N3878600  AU2700 OPA, Item Code: 5996100 N3156700 N9025844  AU5400 OPA, Item Code:  6196400 6196500 6196700 N1257900 N1258000 N3666000 N3877100 N3877200 N3877300 N3877600 N3877700
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) and the countries of Canada, Vietnam, Zambia, and Zimbabwe.
  • 제품 설명
    ISE REF Valve, Part No. MU3226 for the AU400, AU640, AU2700, and AU5400 Chemistry Analyzer. || Automated chemistry analyzers that measures analytes in samples.
  • 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