Events

GLU Reagent 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
    56746
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1619-2011
  • 사례 시작날짜
    2010-08-10
  • 사례 출판 날짜
    2011-03-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-10-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94438
  • 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
    Glucose oxidase, glucose - Product Code CEM
  • 원인
    The recall was initiated because cartridge glucose (glu) on unicel dxc and synchron lx instruments may give falsely high results for moderately hemolysed samples. the impact: (1) neonatal samples drawn by lancets are more likely to be hemolysed to a degree sufficient to cause interference with glucose estimation and are a special at-risk population, (2) other hemolysed samples may be similar.
  • 조치
    The firm, Beckman Coulter, sent an "URGENT: PRODUCT CORRECTIVE ACTION" letter dated August 10, 2010 with an enclosed fax-back Customer Response Form to the customers. The letter provided the customers with an explanation of the problem identified, the impact and an action to be taken. The customers were instructed to run samples using another method/technology and to complete and return the enclosed FAX BACK RESPONSE FORM via fax to (714) 961-4232 or mail to: Beckman Coulter, Inc., Attn: Regulatory Affairs, 250 S. Kraemer Blvd., PO Box 8000, Brea, CA 92822. Firms with questions regarding this Product Corrective Action letter, were instructed to call our Customer Support Center (Hotline) at (800) 854-3633 in the United States and Canada http://www.beckmancoulter.com/customersupport/support/default.asp.

Device

GLU Reagent
  • 모델명 / 제조번호(시리얼번호)
    All non-expired lots
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA and country: Canada.
  • 제품 설명
    GLU Reagent (GLU cartridge assay) used on Synchron LX and UniCel DxC Synchron Clinical Systems, Part Number 442640; || SYNCHRON and UniCel Systems and Part Numbers: || Synchron LX20, Part Number: 466200, || Synchron LX20 PRO, Part Number: 476100, || Synchron LXI 725, Part Number: 476501, || UniCel DxC 600, Part Number: A10405, || UniCel 600 PRO, Part Number: A11810, || UniCel DxC 600i, Part Number: A27318, || UniCel DxC 800, Part Number: A11816, || UniCel DxC 800 PRO, Part Number: A11812, || UniCel DxC 880i, Part Number: A59102, || UniCel DxC 660i, Part Number: A64871, || UniCel DxC 680i, Part Number: A64903, || UniCel DxC860i, Part Number: A64935 || (1) The Synchron LX and UniCel DxC Synchron Clinical Systems are fully automated, computer controlled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whole blood (Sample type is chemistry dependent). (2) GLUCm reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems AQUA CAL 1 and 2, is intended for the quantitative determination of Glucose concentration in human serum, plasma, urine or cerebrospinal fluid (CSF).
  • 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