Events

AllSet = Gold SSP 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Thermo Fisher Scientific Australia Pty 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
    21610
  • 사례 시작날짜
    2017-07-03
  • 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: Bio-Strategy Ltd, 22a William Pickering Drive, North Harbour, Albany, Auckland 0751
  • 원인
    The manufacturer is aware of the allset+ gold ssp kits. the primers pm074d and c15-02a should be negative for the following alleles: :, b*07:219, b*57:02:01, , b*57:02:02, , b*57:03:02, , b*57:07, b*57:09, b*57:12, b*57:17, b*57:28n, b*57:39, b*57:42, b*57:46, b*57:57, b*57:63, b*57:66, b*57:70, b*57:80, b*57:82, b*58:08:01, b*58:08:02, b*58:20, b*58:27, b*58:28:01, b*58:28:02, b*58:65, and b*58:73 during analysis. the lot specific user documents and software uch files contain the incorrect allele specificity information for these two primer mixes.
  • 조치
    Manufacturer to issue advice regarding use

Device

AllSet = Gold SSP

Manufacturer

Thermo Fisher Scientific Australia Pty Ltd