Events

Device Recall Architect AntiHBs Reagent 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
    29922
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1498-04
  • 사례 시작날짜
    2004-08-27
  • 사례 출판 날짜
    2004-09-30
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2005-07-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34786
  • 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
    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) - Product Code LOM
  • 원인
    There is a potential for significant differences in quantitative results for certain specimens when using the affected reagent lots.
  • 조치
    Abbott affiliates in Canada, Germany, Australia, New Zealand, England and Japan were e-mailed copies of the recall letter on 8/27/04 for translation where needed and dissemination to their accounts receiving the suspect lots. The end users were advised of the potential for significant differences in quantitative results for certain specimens and were instructed to discontinue use and destroy any of the affected lots remaining.

Device

Device Recall Architect AntiHBs Reagent
  • 모델명 / 제조번호(시리얼번호)
    list 7C18-20, lots 10014M200, 08672M200, 07780M300 and 17048M100; list 7C18-25, lots 08672M201, 10014M201, 15692M100 and 17048M101; list 7C18-30, lots 09140M300, 09238M200, 08458M200, 02348M300, 10015M200 and 13251M100
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Canada, Japan, Australia, New Zealand, Germany and England
  • 제품 설명
    Architect Anti-HBs Reagent Kit; list 7C18-20, 4 x 100 tests, list 7C18-25, 100 tests and list 7C18-30, 4 x 500 tests; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064
  • Manufacturer
    Abbott Laboratories HPD/ADD/GPRD

Manufacturer

Abbott Laboratories HPD/ADD/GPRD
  • 제조사 주소
    Abbott Laboratories HPD/ADD/GPRD, 100 Abbott Park Rd, Abbott Park IL 60064-3502
  • Source
    USFDA