Events

Various Microgenics Application Sheets 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Microgenics Corporation 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
    21578
  • 사례 시작날짜
    2017-06-28
  • 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: Thermo Fisher Scientific New Zealand Ltd, 244 Bush Road, Albany, AUCKLAND
  • 원인
    During an internal assessment, it was found that certain application sheets provided by thermo fisher new zealand for expanded use of some assays on analyzers that are not listed in the assay instructions for use are inadequate. specifically, the validation data included in the application sheets for the expanded use of these assays, is inadequate and will not be included in future application sheets. in addition, statements have been added to the application sheets that explain that the parameter settings are not supplier qualified and are to be used for instrument programming guidance only, and that each assay used on a non-microgenics approved analyzer needs to be validated individually by the user.
  • 조치
    Instructions for use to be updated

Device

Various Microgenics Application Sheets
  • 모델명 / 제조번호(시리얼번호)
    Model: , Affected: Incomplete Instructions for Use for Microgenics Application Sheets
  • Manufacturer
    Microgenics Corporation

Manufacturer

Microgenics Corporation