Events

Biomerieux Vitek MS Instrument 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Kratos Analytical 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
    15506
  • 사례 시작날짜
    2014-10-02
  • 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: BioMerieux New Zealand Ltd, Suite 4, The Business Connection Office, 2 Kalmia Street, Auckland 1544
  • 원인
    The vitek ms instrument is equipped with a transient recorder (tr) board associated with a specific firmware. this association is used to compute the time of flight of detected ions. some issues have been reported when firmware version 3.13 was installed on systems equipped with the old tr board (ref. 6200350). extensive testing has proven that firmware 3.13 may potentially cause an instrument to freeze or hang during acquisition when installed with the old tr board, with a risk of repeated results for different spots.
  • 조치
    Software to be upgraded

Device

Biomerieux Vitek MS Instrument
  • 모델명 / 제조번호(시리얼번호)
    Model: , Affected: All instruments with a Serial Number lower than #50039, Serial Number #50050, or Serial Number greater than #60000
  • Manufacturer
    Kratos Analytical Ltd

Manufacturer

Kratos Analytical Ltd