Events

IH-1000. An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Bio-Rad Laboratories Pty Ltd 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
    RC-2013-RN-00593-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-06-13
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00593-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    In some specific conditions, inconsistent grading between the results in the well/card and the results returned by the ih-1000 may be observed. in these very specific conditions, positive reactions might be read as negative by the system due to the analysis algorithm of the images. therefore this issue might lead to a wrong result released to the host if the 3 following conditions are met:1 a result is returned as negative while the reaction is positive, double population, or requires a human interpretation and, 2. this negative result is consistent with the global interpretation of the test and, 3. the system is configured without the second reading function activated for all tests results.
  • 조치
    Bio-Rad are providing work around instructions as an interim measure. A software update will be implemented to permanently correct the issue.

Device

IH-1000. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    IH-1000. An in vitro diagnostic medical device (IVD)All software versions are affectedProduct reference: 001000ARTG Number: 184446
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd