Events

ADVIA Chemistry Hemoglobin A1c_3 Reagent 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Siemens Healthcare Diagnostics, 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
    72392
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0340-2016
  • 사례 출판 날짜
    2015-11-25
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-01-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140899
  • 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
    Assay, glycosylated hemoglobin - Product Code LCP
  • 원인
    Reagent in these lots may demonstrate an increased occurrence of high %hba1c bias, a positive bias averaging 0.6% hba1c units, ranging from -0.1% to 1.1% hba1c units. the maximum bias was observed at higher %hba1c concentrations. qc samples may exhibit a similar bias.
  • 조치
    Siemens has issued an Urgent Medical Device Recall in the US and an Urgent Field Safety Notice Outside the US on September 24, 2015, instructing customers to discontinue use, discard reagent and request no charge replacement kits for these products.

Device

ADVIA Chemistry Hemoglobin A1c_3 Reagent
  • 모델명 / 제조번호(시리얼번호)
    10379673 (160 tests kit), 10485591 (800 tests kit) Lot 230 (SMN 10485591 and 10379673) and lot 231(SMN 10485591)
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed in the states of AZ, NY, CA, IN, LA, MN, OH, MI, NM, and GA, and the countries of Mexico and Canada.
  • 제품 설명
    ADVIA Chemistry Hemoglobin A1c_3, A1c_3M Reagent kits. Used on the ADVIA 1200, 1650, 1800, 2400, and XPT Chemistry Systems. For in vitro diagnostic use in the quantitative determination of Hemoglobin A1c, a diabetes marker, in whole blood on the ADVIA Chemistry systems.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • 제조사 주소
    Siemens Healthcare Diagnostics, Inc., 500 Gbc Dr Ms 514, PO BOX 6101, Newark DE 19702-2466
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA