Events

Device Recall UniCel Access Immunoassay Systems 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
    69107
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2687-2014
  • 사례 시작날짜
    2014-08-21
  • 사례 출판 날짜
    2014-09-23
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-04-30
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129652
  • 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
    Beckman coulter is recalling the sample probe cable because nonconforming sample probe cables may been installed on newly manufactured and/or recently serviced unicel dxi 600 and 800 access immunoassay systems, unicel dxc 660i, 680i, and 860i, and unicel dxc 880i synchron access clinical systems instruments. use of a nonconforming sample probe cable can casuse a delay in reporting results, but wi.
  • 조치
    A customer notification letter dated 8/21/14 was sent to all customers who purchased the Sample Probe Cable for use with the UniCel DxI Family of Immunoassay Systems. The letter informs the customers of the problems identified and the actions to be taken. Customer are instructed to complete and return the enclosed response form within 10 days. Customers are instructed to call (800) 854-3633 in US and Canada.

Device

Device Recall UniCel Access Immunoassay Systems
  • 모델명 / 제조번호(시리얼번호)
    Sample probe cables, Lot number 2014.  Serial No.  600785 601704 900359 900950 601257 600968 900613 604013 603950 604006 603963 603972 604002 604008 603995 604004 603939 603940 603932 603934 603978 603998 604009 603948 603945 603977 603956 603933 604007 603929 604019 604017 604012 603935 603941 603997 603996 604000 603976 604014 601897 604005 603955 603944 603942 601801 603962 603928 603992 603993 603982 603991 603971 603970 603983 603980 603964 603986 603985 603984 603967 603981 603969 603994 603943 603957 603953 604001 604016 603973 900939 603951 600525 900231 601251 603936 601831 603545 6303547 602589 900913 603859 603860 900368 900935 603078 900782 601493 606694 603693 602113 602595 900933 603917 600571 601220 601265 603013 600794 600306 601718 602771 602782 601925 600758 600857 603007 601658 603717 602020 601894 600891 600882 600980 602036 603539 603706 603975 900940 603999 601510 601381 900947 601624 603946 603949 603947 603952 603016 602996 603974 601509 601513 601928 900834 600931 600693 600511 600341 900264 601969 601109 600113 601791 600959 603931 603966 600680 601305 601872 603503 603125 603915 603988 601255 604003 603965 603989 900851 900826 601984 602278 900765 602356 900581 600343 900948 602313 900057 600912 602360 601828 601745 900722 601764 601210 602533 900566 900539 603879 900928 900927 900949 900212 900065 601724 601827 900796 900951 900946 603694 900941 900930 900929 600233 603938 603954 900936 600657 604015 601567 603147 900944 900938 603765 900632 603968 604010 900937 900636 603752 900531 900429 603930 603937 900932 601967 604011 603979 603987 900931 900710 900934 601622 602561 900426 603961 603959 603958 603960 900592 603473 900943 900952 900945 603865
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide in US and worldwide: Canada, China, Colombia, Croatia, Czech Republic, France, Germany, India, Italy, Japan, Korea, Kuwait, Malaysia, Mexico, Philippines, Puerto Rico, Russia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States, Vietnam.
  • 제품 설명
    UniCel 600/800 Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids. The cables and kits are used in UniCel DxI 600, 800 instruments, and are distributed to Beckman and Non-Beckman Service Engineers for replacement of worn and/or damaged parts during field services calls.
  • 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