Events

Device Recall AEROSET 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Abbott Laboratories Diagnostic Div 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
    27178
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0165-04
  • 사례 시작날짜
    2002-07-31
  • 사례 출판 날짜
    2004-07-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2003-11-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29368
  • 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
    Igm, Antigen, Antiserum, Control - Product Code DFT
  • 원인
    Assay may produce falsely low igm results without error codes when testing specimens contain elevated serum paraproteins associated with various myeloma or other malignancies.
  • 조치
    Consignees were provided with assay parameters for the RCD flag which may enhance the detection of these type of specimens. The assay parameter settings for the RCD flag were distributed to all AEROSET consignees in the United States by direct mail and to country managers worldwide via a Product Information letter dated July 31, 2002. Also provided with the Product Information letter was an AEROSET IgM Application Sheet containing the updated assay parameters for the RCD flag.

Device

Device Recall AEROSET
  • 모델명 / 제조번호(시리얼번호)
    All lots
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide to the following states: Texas, Illinois, Indiana, Tennessee, Alaska, Pennsylvania, New York, Florida, Massachusetts, Missouri, Alabama, North Carolina, California, Ohio, Utah, Michigan, Arizona, Wisconsin, Oklahoma, Maine, Kansas, Georgia, Mississippi, Connecticut, Rhode Island, Washington, Wyoming, Louisiana, Washington, Maryland, New Jersey, Arkansas, Iowa, South Carolina, Colorado, Minnesota, North Dakota, and West Virginia. Worldwide to the following countries: Argentina, Australia, Brazil, Germany, England, Canada, Chile, Colombia, Dominican Republic, Denmark, France, Hong Kong, Japan, Korea, Singapore, Guatemala, New Zealand, Thailand, Turkey, Spain, Italy, South Africa, Sweden, Greece, Portugal, Venezuela, Pakistan, Finland, Ireland, and Taiwan.
  • 제품 설명
    AEROSET Immunoglobulin M, list number 1E01-01, manufactured by Abbott Laboratories, South Pasadena, CA
  • Manufacturer
    Abbott Laboratories Diagnostic Div

Manufacturer

Abbott Laboratories Diagnostic Div
  • 제조사 주소
    Abbott Laboratories Diagnostic Div, 820 Mission Street, South Pasadena CA 91030
  • Source
    USFDA