Events

Device Recall Coulter LH 780 Hematology Analyzer 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
    66826
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0471-2014
  • 사례 시작날짜
    2013-11-08
  • 사례 출판 날짜
    2013-12-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-12-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123612
  • 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
    Counter, differential cell - Product Code GKZ
  • 원인
    Beckman coulter is recalling the lh 750 and lh 780 hematology systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nrbc), white blood cell differential and/or reticulocytes.
  • 조치
    Beckman Coulter sent an customer notification letter dated 11/8/13 to all customers who purchased the LH 750 and LH 780 Hematology Systems. 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's Customer Support Center at http://www.beckmancoulter.com/customer/support or call (800) 526-7694 in the US and Canada. Outside the US and Canada, customers are instructed to contact Beckman Coulter Representative. On 2/17/14, Beckman Coulter expanded the recall to inform Coulter LH 750 and Coulter LH 780 Hematology Analyzer customers of the issue related to LH Cleaner and Coulter Clenz.

Device

Device Recall Coulter LH 780 Hematology Analyzer
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribtion - USA Nationwide including the countries of Algeria, Andorra, Angola, Australia, Austria, Bahrain, Bangladesh, Belgium, Bermuda, Bosnia and Herzegovina, Bulgaria, China, Colombia, Croatia, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic of, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Macao, Malaysia, Mayotte, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Viet Nam, Virgin Islands, U.S., and Zimbabwe.
  • 제품 설명
    Coulter LH 780 Hematology Analyzer, Part No. 723585, || A90728 || Product Usage: || Coulter LH 780 Hematology Analyzer is a is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The Coulter¿ LH 780 Hematology Analyzer also provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids.
  • 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