Events

XN-L series analyser 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Sysmex 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
    21663
  • 사례 시작날짜
    2017-07-05
  • 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: Roche Diagnostics (NZ) Ltd, 15 Rakino Way, Mt Wellington, AUCKLAND 1644
  • 원인
    It has been reported that the wbc could become falsely low when the following steps are performed:, manual mode is selected, whole blood mode (wb), predilute mode (pd) or body fluid mode (bf) is changed to low wbc mode (lw)., the measurement information is input in the manual order dialogue and the menu is closed by selecting 'ok'., no measurement is performed in lw mode, and the mode is then changed to use another measurement mode (ie either wb, pd, bf)., with the next measurement, the wbc result becomes diluted and gives a result half of the correct wbc value.
  • 조치
    Software to be upgraded

Device

XN-L series analyser
  • 모델명 / 제조번호(시리얼번호)
    Model: , Affected: XN-L series instruments: version 00-13 and above
  • Manufacturer
    Sysmex Corporation

Manufacturer

Sysmex Corporation