Events

Biomerieux ZYM B Reagent 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
    15663
  • 사례 시작날짜
    2013-11-14
  • 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 manufacturer has identified a vusual defect and activity issue of the zym b reagent which is used as an additional test for revealing the results of some miniaturized tests included in api nh and api listeria. a risk analysis has been done to assess the impact of the zym b activity issue on the test results. the investigations concluded that it could lead to misidentificiation of some species with api strep, api nh, api listeria and api coryne.
  • 조치
    Product to be destroyed

Device

Biomerieux ZYM B Reagent
  • 모델명 / 제조번호(시리얼번호)
    Model: 70493, Affected: Multiple
  • Manufacturer
    Biomerieux SA

Manufacturer

Biomerieux SA