Events

Device Recall AxSYM Homocysteine Reagent Pack 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Abbott Laboratories HPD/ADD/GPRD 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
    27069
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1218-03
  • 사례 시작날짜
    2003-08-22
  • 사례 출판 날짜
    2003-09-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2004-07-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29126
  • 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
    Urinary Homocystine (Nonquantitative) Test System - Product Code LPS
  • 원인
    There is a kit-to-kit difference within the lots, with the reagents generating different polarization values than those in others.
  • 조치
    Recall letters dated 8/22/03 informed users of the kit to kit difference within the lots, and outlined the actions needed to take for patient results obtained from the use of the affected kits. The customers were requested to destroy any remaining inventory of the affected reagents. Any questions were directed to Abbott's Customer Service at 1-877-422-2688.

Device

Device Recall AxSYM Homocysteine Reagent Pack
  • 모델명 / 제조번호(시리얼번호)
    list 5F51-20, lots 01724M300, 03314HN00, 03533HN00
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Lot 01724M300 was distributed nationwide, as well as to Canada, Singapore, Tahiland, Korea, Hong Kong and China. Lots 03314HN00 and 03533HN00 were distributed by Abbott's Delkenheim, Germany subsidiary worldwide outside of the United States. These two lots were not distributed in the U.S.
  • 제품 설명
    AxSYM Homocysteine Reagent Pack, list 5F51-20, Produced by Axis-Shield, Oslo, Norway, for Abbott Laboratories, Abbott Park, IL 60064 USA
  • Manufacturer
    Abbott Laboratories HPD/ADD/GPRD

Manufacturer

Abbott Laboratories HPD/ADD/GPRD
  • 제조사 주소
    Abbott Laboratories HPD/ADD/GPRD, 100/200 Abbott Park Road, Abbott Park IL 60064
  • Source
    USFDA