Events

Bio-Rad- IH-1000 Analyser 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Bio-Rad Laboratories 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
    14800
  • 사례 시작날짜
    2013-06-13
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Bio-Rad Laboratories Ltd, 189 Bush Road, Rosedale, AUCKLAND 0632
  • 원인
    Under specific conditions inconsistent grading between the results in the well/card and the results returned by the ih-1000 may be observed., this issue might lead to a wrong result released to the host if all the 3, following conditions are met:, 1. a result is returned as negative while the reaction is positive, dp, 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
    Software to be upgraded

Device

Bio-Rad- IH-1000 Analyser
  • 모델명 / 제조번호(시리얼번호)
    Model: Model: 001000, Affected: All software versions
  • Manufacturer
    Bio-Rad Laboratories Inc

Manufacturer

Bio-Rad Laboratories Inc