Events

Tosoh 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Tosoh Bioscience, 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
    30183
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-0218-05
  • 사례 시작날짜
    2003-04-02
  • 사례 출판 날짜
    2004-11-30
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2005-06-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35321
  • 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
    System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer - Product Code NIG
  • 원인
    A software upgrade was released by the firm for its aia-600 ii analyzers, in that washing deficiencies caused by the analyzer were corrected.
  • 조치
    The firm initiated the correction on 4/2/03 via telephone calls and PR on 11/24/04 to all its direct customers, however, the firm indicated that software upgrade was accomplished by the firm's Field Service Engineers.

Device

Tosoh
  • 모델명 / 제조번호(시리얼번호)
    All units of these models.
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    81 customers received the upgrade, including customers who received instruments with the upgrade installed already. 37 customers received the v.3.12 installation. In addition, TOSOH bioscience has identified 3 foreign and 5 US customers who required the upgrade. The firm had distributed to 3 US Government medical centers as well. These upgrades have been completed.
  • 제품 설명
    TOSOH brand AIA-600 II Enzyme Immunoassay Analyzer; Software version 3.12, Catalog Numbers 019359, 019400; Model 019400, Smart Media
  • Manufacturer
    Tosoh Bioscience, Inc.

Manufacturer

Tosoh Bioscience, Inc.
  • 제조사 주소
    Tosoh Bioscience, Inc., 347 Oyster Point Blvd Ste 201, South San Francisco CA 94080-1913
  • Source
    USFDA