Events

IsMeasles IgG Enzyme Immunoassay Test Kit 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Diamedix Corporation 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
    50162
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0607-2009
  • 사례 시작날짜
    2008-10-10
  • 사례 출판 날짜
    2009-01-07
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-05-12
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74884
  • 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
    Rubeola (measles) virus serological reagents. - Product Code LJB
  • 원인
    Possible false-negative test results: the sample a diluent lot # 50768 assigned to is-measles igg lot #'s 41108 and 41108b has higher conductivity than normal, which can sporadically interfere with the mago plus/aptus sensing of and picking up of samples. as a result, if the sample is not picked up/processed, it could lead to the possibility of obtaining false negative results in some cases.
  • 조치
    Notification of all domestic customers via Certified Mail. Notification of the one international customer via Federal Express.

Device

IsMeasles IgG Enzyme Immunoassay Test Kit
  • 모델명 / 제조번호(시리얼번호)
    Lot number 41108 and 41108B
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution --- including USA and country of England.
  • 제품 설명
    Measles IgG Enzyme Immunoassay Test Kit, DIAMEDIX. The assay is intended for the semi-quantitation of human IgG antibodies to measles virus in human serum by indirect immunoassay to aid in the assessment of the patient's immunological response to measles virus, to determine the immune status of individuals and, when evaluating paired sera, as an aid in the diagnosis of measles infection.
  • Manufacturer
    Diamedix Corporation

Manufacturer

Diamedix Corporation
  • 제조사 주소
    Diamedix Corporation, 2140 N. Miami Avenue, Miami FL 33127
  • Source
    USFDA