Events

Device Recall ARCHITECT STAT TroponinI Reagent 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Abbott Laboratories MPG 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
    37570
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-0855-2007
  • 사례 시작날짜
    2007-03-08
  • 사례 출판 날짜
    2007-06-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-07-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50814
  • 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
    Troponin-I Reagent - Product Code MMI
  • 원인
    False negative results : the analytical sensitivity claim of less than or equal to 0.01 ng/ml (ug/l) might not be met for all lots of architect stat troponin-i reagents, thus false negative results may occur with negative results less than 0.1 ng/ml.
  • 조치
    Abbott sent a Product Correction letter on 3/8/07 to all Troponin-I customers who received reagent lots in the last 12 months. The letters informed the accounts that the analytical sensitivity claim of

Device

Device Recall ARCHITECT STAT TroponinI Reagent
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers 11455C006, 11605UN06, 12072UN06, 14818UN06, 13037UN06, 12990UN06, 12982UN06, 11456C006, 11609UN06, 14817UN06, 14339UN06, 13590UN06, 12986UN06, 14350UN06, 13122UN06, 12978UN06, 11370C006
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide: USA including Puerto Rico, and internationally to Canada, Brazil, Germany, Japan, Taiwan, Hong Kong, Thailand, South Korea, Australia, New Zealand, Mexico, Colombia, Chile, Argentina and Trindad & Tobago.
  • 제품 설명
    ARCHITECT STAT Troponin-I Reagent; list numbers 2K41-20 (400 test kit), 2K41-25 (100 test kit) and 2K41-30 (2000 test kit); each kit contains bottles of microparticles, conjugate and assay diluent; Abbott Laboratories, Abbott Park, IL 60064
  • Manufacturer
    Abbott Laboratories MPG

Manufacturer

Abbott Laboratories MPG
  • 제조사 주소
    Abbott Laboratories MPG, 100 Abbott Park Rd, Abbott Park IL 60064-3502
  • Source
    USFDA