Events

Nichols Advantage® Bio-Intact PTH (1-84) 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 Nichols Institute Diagnostics 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
  • 날짜
    2005-04-12
  • 사례 국가
    France
  • 사례 출처
    ANSM
  • 사례 출처 URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-lots-dmdiv-nichols-advantage-r-bio-intact-pth-1-84-nichols-institute-diagnostics
  • 비고 / 경고
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • 데이터 추가 비고
  • 조치
    On April 8, 2005, Nichols Institute Diagnostics withdrew lots 62-402622, 62-402622B, 62-402622C, 62-402622D from the in vitro diagnostic medical device known as Nichols Advantage® Bio-Intact PTH (1-84). ) reference 62-7040 following the demonstration that these batches were no longer in conformity with the information indicated in the instructions for use, concerning functional sensitivity, reproducibility, parallelism and recovery. This device is used with the Nichols Advantage® specialized automaton for measuring parathyroid hormone levels in serum, EDTA plasma and heparinized plasma. The relevant European Competent Authorities are informed directly by the manufacturer. This information is intended for those responsible laboratories, the directors of health establishments and the reactive vigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

Nichols Advantage® Bio-Intact PTH (1-84)

Manufacturer

Nichols Institute Diagnostics
  • Source
    LAANSM