Events

Device Recall CELLDYN 1700 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Abbott Laboratories 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
    53212
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1628-2010
  • 사례 시작날짜
    2009-06-08
  • 사례 출판 날짜
    2010-05-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-12-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84992
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • 데이터 추가 비고
    multiparameter hematology analyzer - Product Code gkz
  • 원인
    Use of syringe ln 04h36-01 with the die-cast syringe drive may result in leakage, leading to delay in reporting patient results.
  • 조치
    A Product Correction Letter and Customer Rely Form were sent to all currently active Cell -Dyn Sapphire customer. New customers are being notified with a Product Information Letter. For questions regarding this information, U,S, customers should call Customer Support at 1-877-4ABBOTT. Customers outside the U.S., please contact your local hematology customer support representative.

Device

Device Recall CELLDYN 1700
  • 모델명 / 제조번호(시리얼번호)
    Control Number 53278U96 53388U96 54924U96 50092U96 50230U96 50411U96 50617U96 50690U96 50770U96 50829U96 50849U96 50863U96 50867U96 50964U96 51012U96 51059U96 51160U96 51243U96 51484U96 51498U96 51509U96 51583U96 51828U96 51873U96 51886U96 51918U96 52119U96 52199U96 52294U96 52297U96 52364U96 52383U96 52390U96 52611U96 52716U96 52832U96 52894U96 53022U96 53069U96 53187U96 53238U96 53243U96 53280U96 53285U96 53307U96 53327U96 53431U96 53474U96 53481U96 53543U96 53582U96 53627U96 53647U96 53705U96 53787U96 53790U96 53796U96 53803U96 53818U96 53916U96 54017U96 54044U96 54133U96 54156U96 54177U96 54194U96 54198U96 54211U96 54266U96 54298U96 54302U96 54329U96 54371U96 54380U96 54384U96 54432U96 54448U96 54450U96 54468U96 54489U96 54499U96 54518U96 54563U96 54578U96 54587U96 54590U96 54591U96 54606U96 54611U96 54618U96 54687U96 54702U96 54732U96 54743U96 54744U96 54745U96 54747U96 54762U96 54774U96 54790U96 54806U96 54818U96 54839U96 54893U96 54904U96 54951U96 54953U96 54967U96 54968U96 54982U96 55067U96 55132U96 55147U96 55185U96 55205U96 55266U96 55299U96 55303U96 55308U96 55311U96 55344U96 55400U96 55428U96 55466U96 55510U96 55511U96 55519U96 55520U96 55522U96 55523U96 55552U96 55555U96 55622U96 55639U96 55644U96 55679U96 55804U96 55805U96 55844U96 55866U96 55869U96 55880U96 55955U96 55961U96 56110U96 56140U96 56145U96 56164U96 56169U96 56204U96 56269U96 56365U96 56393U96 56407U96 56418U96 56424U96 56478U96 56495U96 56500U96 56604U96 56625U96 56658U96 56690U96 56699U96 56728U96 56772U96 56820U96 56821U96 56840U96 56846U96 56848U96 56859U96 56861U96 56870U96 56872U96 56873U96 56934U96 56941U96 56980U96 56981U96 56986U96 56991U96 56994U96 57107U96 57141U96 57142U96 57170U96 57187U96 57230U96 57262U96 57331U96 57335U96 57360U96 57403U96 57564U96 57565U96 57566U96 57567U96 57568U96 57569U96 57563U96 51565U96 51593U96 51913U96 51982U96 52098U96 53587U96 53988U96 54041U96 54117U96 55003U96 55080U96 55242U96 55262U96 55268U96 55277U96 55598U96 55631U96 55673U96 55757U96 55815U96 56692U96 56866U96 57334U96 55155U96 55236U96 55294U96 55385U96 55410U96 55413U96 55421U96 55912U96 55964U96 56015U96 562217U96 56567U96 56734U96 56835U96 57437U96 55292U96 56757U96 50368U96 50373U96 50826U96 51175U96 51647U96 52737U96 53273U96 53500U96 53663U96 53670U96 53717U96 53732U96 53862U96 54247U96 55018U96 55032U96 55274U96 55305U96 55342U96 55412U96 55642U96 55794U96 56175U96 56188U96 56248U96 56334U96 56380U96 56526U96 56541U96 56982U96 53389U96 54287U96 55295U96
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: United States, Canada, Mexico, Anguilla, Australia, Argentina, Belize, Bermuda, Brazil, China, Chile, Columbia, Costa Rica, Ecuador, El Salvador, Germany, Guatemala, Haiti, Honduras, Hong Kong, Japan, Paraguay, Peru, Puerto Rico, Singapore, South Korea, Uruguay, and Venezuela.
  • 제품 설명
    CELL-DYN 1700, list numbers 03H5301 and 03H53-03, manufactured by Abbott Hematology, Santa Clara, CA
  • Manufacturer
    Abbott Laboratories

Manufacturer

Abbott Laboratories
  • 제조사 주소
    Abbott Laboratories, 5440 Patrick Henry Dr, Santa Clara CA 95054-1113
  • Source
    USFDA