Events

Device Recall Coulter LH 500 Series 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
    55176
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-1657-2010
  • 사례 시작날짜
    2010-02-04
  • 사례 출판 날짜
    2010-05-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-09-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90220
  • 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
    Issue 1: the system will substitute or omit the characters # @ [\] ' {i) when the system is configured in a language other than english or chinese. example: using the character @, a substitution in the string '123@456' would result in '123#456' and an omission would result in '123456' issue 2: the system will omit the character ~ regardless of language. impact: there is a potential for specimen.
  • 조치
    Beckman Coulter, Inc. issued "Urgent: Product Corrective Action" notifications dated February 12, 2010. Consignees were informed of the affected product and instructed on proper actions. The firm also asked that the enclosed response forms be returned. For further information, contact your local Beckman Coulter Representative or call 1-800-526-7694.

Device

Device Recall Coulter LH 500 Series System
  • 모델명 / 제조번호(시리얼번호)
    Product LH500 100V Part number 178832; Product LH500 120V Part number 178833; Product LH500 240V Part Number 178834; All Serial Numbers.
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed Nationwide and Canada.
  • 제품 설명
    Coulter¿ LH 500 Series System. Beckman Coulter, Inc. Brea, CA. || Quantitative, automated hematology analyzer and leukocyte differential cell counter for in vitro diagnostic use in clinical laboratories.
  • 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