Events

Bio-Rad IH-Com Kit Fullversion (Data management and result Interpretation) 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
    13871
  • 사례 시작날짜
    2012-12-04
  • 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
    In case of non interpretable results in the anti-ab well (abo3) of id-cards intended for abo forward grouping, the ih-com software does not include the reaction of this well (result code-30) wheh sending the result to the laboratory host. the issue can only occur if the following conditions are met:, 1. ih-com software is connected to the laboratory host through astm communication mode and,, 2. an "abo not interpretable" result is obtained due to a reaction "?" or "+/-" or "dp" in the anti-abwell of an id-card ** intended forabo forward grouping and, 3. the "second reading" option is deactivated and in-com results are directly sent to the host, or, 4. the "second reading" option is activated but the "not interpretable" result obtained in ih-com is directly saved and sent to the host without a manual selection by the user in abo scrollbar.
  • 조치
    Software to be upgraded

Device

Bio-Rad IH-Com Kit Fullversion (Data management and result Interpretation)
  • 모델명 / 제조번호(시리얼번호)
    Model: Item number: 09000, Affected: Lot Number: 03.043/03.052/03.0.59
  • Manufacturer
    Bio-Rad Laboratories Inc

Manufacturer

Bio-Rad Laboratories Inc