Events

Roche Cepheid LightCycler VZV Quality Kit 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Cepheid AB 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
    17438
  • 사례 시작날짜
    2014-09-29
  • 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
    Users are requested to discontinue the use and discard any remaining inventory of specific lots of the lightcycler® vzv qual kit, ce-ivd which, due to kit stability issues, can lead to invalid results. due to the stability issues, positive control (pc) and non-template control (ntc) failures may be generated. previously generated, valid results do not need to be questioned or repeated.
  • 조치
    Product to be destroyed

Device

Roche Cepheid LightCycler VZV Quality Kit
  • 모델명 / 제조번호(시리얼번호)
    Model: GMMI 04846788001, Affected: Lots: 70012381, 70012383, and 70012389
  • Manufacturer
    Cepheid AB

Manufacturer

Cepheid AB