Events

Bio-Rad IH-1000 software 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
    17647
  • 사례 시작날짜
    2014-11-07
  • 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
    Bio-rad has confirmed that under specific conditions, the ih-1000 software may lose the link sample/"test in progress". this loss, might, in the worst case, lead to a mismatch between the test result and the sample., this issue is linked to the sample management when using the "emergency* button" and might occur only in the following conditions:, 1. a not urgent rack (green label) is inserted with more than one sample and ;, 2. all the samples on this rack are manually selected as "emergency" by clicking on the "emergency* button";, then once the first emergency sample is processed, the instrument ejects the rack before all processing is completed., 3. if a rack is then reloaded with new samples in the exact same positions and reinserted in the same slot, the link sample/"test in progress" is lost.
  • 조치
    Software to be upgraded

Device

Bio-Rad IH-1000 software
  • 모델명 / 제조번호(시리얼번호)
    Model: Catalogue Number: 001000V, Affected: , Software version: All versions
  • Manufacturer
    Bio-Rad Laboratories Inc

Manufacturer

Bio-Rad Laboratories Inc