Events

ETEST Teicoplanin 256 (TP) SPB and Foam packaging 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
    22388
  • 사례 시작날짜
    2017-12-20
  • 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
    Following an assessment of etest teicoplanin with staphylococcus spp., we observed an underestimation of mic values by at least 1 dilution for coagulase negative staphylococci (cons); even though the mic essential agreement at +/- 1 dilution is > 95% between etest tp256 and the reference method agar dilution (ad) for staphylococcus spp.
  • 조치
    Manufacturer to issue advice regarding use

Device

ETEST Teicoplanin 256 (TP) SPB and Foam packaging
  • 모델명 / 제조번호(시리얼번호)
    Model: , Affected: Catalogue number Foam: 412461 & 522018, Pack size 30 and 100
  • Manufacturer
    Biomerieux SA

Manufacturer

Biomerieux SA