Events

Dihydrotestosterone (DHT) RIA 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 manufacturer #1479 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
    21303
  • 사례 시작날짜
    2017-04-10
  • 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: Abacus ALS Limited, 55b Richard Pearse Drive, Airport Oaks, Auckland 2022
  • 원인
    The manufacturer noticed that the kmno4 reagent (#3205213) - lot 16h8 - included in the dihydrotestosterone (dht) ria kit may lead to elevated concentrations, especially for male samples. the impact of the affected kmno4 (lot 16h8) was less visible on female samples. because this reagent is used in the extraction step, elevated values were not observed on the standard curve nor on the kit controls. only extracted samples are susceptible to higher results.
  • 조치
    Product to be exchanged

Device

Dihydrotestosterone (DHT) RIA
  • 모델명 / 제조번호(시리얼번호)
    Model: , Affected: Cat. Number. DE5170, Lot. 164808/C
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479