Events

Simtomax In vitro screening test for Coeliac Disease 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Augurix 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
    19941
  • 사례 시작날짜
    2016-03-29
  • 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: Smith Biomed (NZ) Ltd, P O Box 8108, Level 2, 44B Victoria Road, New Plymouth
  • 원인
    Due to an issue with over labelling of the simtomax coeliac disease test the expiry dates may not correctly match the stock supplied. the efficacy of the test is not in question however stock received may not necessarily reflect the correct batch that should have been received. the tests are not past their expiry date and the tests that consumers have taken to date had not expired and the efficacy of the test is not in question.
  • 조치
    Product to be returned to supplier

Device

Simtomax In vitro screening test for Coeliac Disease
  • 모델명 / 제조번호(시리얼번호)
    Model: , Affected: Batches: 192065, 195218, 195220 and 195378
  • Manufacturer
    Augurix SA

Manufacturer

Augurix SA