Events

The Binding Site Group Human IgM kit for use on SPA Plus 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 The Binding Site Group Ltd 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
    15787
  • 사례 시작날짜
    2013-12-03
  • 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: In Vitro Technologies, 26-30 Vestey Drive, Mount Wellington, Panmure, Auckland
  • 원인
    Manufacturer investigations identified that the affected product may be subject to antigen excess effect; even though it's true value was below the claimed level of 56.4g/l. the antigen excess capacity of this product has been reviewed and has been confirmed as correct. investigations have suggested that the tested sample contained predominantly monoclonal igm and the manufacturer believes that this particular type of igm reacted aberrantly with the antibody and subsequently yielded the spurious result.
  • 조치
    Instructions for use to be updated

Device

The Binding Site Group Human IgM kit for use on SPA Plus
  • 모델명 / 제조번호(시리얼번호)
    Model: NK012.S and NK012.10S, Affected: all lot numbers
  • Manufacturer
    The Binding Site Group Ltd

Manufacturer

The Binding Site Group Ltd