Events

ETEST® XM256 (Cefuroxime) 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Biomerieux SA 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
    21145
  • 사례 시작날짜
    2017-02-23
  • 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: Medi'Ray New Zealand Ltd, 53-55 Paul Matthews Road, Albany, Auckland 0632
  • 원인
    Investigation confirmed a potential performance issue on strain categorization for streptococcus pneumoniae and for enterobacteriaceae strains limited to oral cefuroxim breakpoints and based on 2016 clsi clinical standards only., for streptococcus pneumoniae on etest® xm256 (cefuroxime) foam and spb could lead to minor error on clinical strains:, o false susceptible result instead of intermediate results with bmd (broth micro dilution) reference method, o false intermediate result instead of resistant results with bmd reference method, for enterobacteriaceae on etest® xm256 (cefuroxime) foam and spb could lead to minor error on clinical strains:, o false susceptible result instead of intermediate results with ad (agar dilution) reference method, o false intermediate result instead of resistant results with ad reference method.
  • 조치
    Manufacturer to issue advice regarding use

Device

ETEST® XM256 (Cefuroxime)
  • 모델명 / 제조번호(시리얼번호)
    Model: , Affected: ETEST XM256 (Cefuroxime) WW SPB lot number1002884720, ETEST XM256 (Cefuroxime) WW SPB lot number 1003383650, ETEST XM256 (Cefuroxime) WW Foam lot number 1003075850, ETEST XM256 (Cefuroxime) WW Foam lot number 1003385930
  • Manufacturer
    Biomerieux SA

Manufacturer

Biomerieux SA