COULTER LH780 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
    44916
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0313-2008
  • 사례 시작날짜
    2007-04-18
  • 사례 출판 날짜
    2007-12-22
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-04-16
  • 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
    Beckman Coulter, Brea, CA. (Hematology analyzer) - Product Code GKZ
  • 원인
    Patient mis-identification can occur: 1)- when a positive identifier (sample id or cassette/position) is manually edited to a positive identifier that is already in the to do list. the workstation will accept the entry and no error message will be generated, creating 2 samples with the identical positive identifier. 2)- when manually entering a patient id, if a blank space is entered between th.
  • 조치
    Product Corrective Action (PCA) letters were mailed on April 18,2007, to all GENS, LH500, LH750 and LH780 accounts. They are informed that a potential misidentification can occur in 2 scenarios. 1. When a positive identifier (Sample ID or CassetteIPosition) is manually edited to a positive identifier that is already in the ToDo list. The workstation will accept the entry and no error message will be generated, creating 2 samples with the identical positive identifier. 2. When manually entering a Patient ID, if a blank space is entered between the characters in the Patient ID field, the system will only accept the characters before the space.----Short term fix----- The letter explains the issues and provides the customer work around. (Letters were sent by US mail). A customer response form was provided. The root cause of the problem is still under investigation, software upgrades, when approved will be made to devices.

Device

  • 모델명 / 제조번호(시리얼번호)
    Part Number 723585. All software versions
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    World wide: USA and Canada
  • 제품 설명
    COULTER LH780 Analyzer , Part Number: 723585, Beckman Coulter, Brea, CA. (Hematology analyzer)
  • Manufacturer

Manufacturer

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