Events

Nichols Advantage® ACTH 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 DPC France 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
    2005-05-30
  • 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-d-un-lot-du-dmdiv-nichols-advantage-r-acth-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 May 26, 2005, Nichols Institute Diagnostics withdrew from the market Lot 62-500040 (Per 20.06.05) of the in vitro diagnostic medical device known as Nichols Advantage® ACTH Reference 62-7004 following the identification of the nonconformity of this batch with the information indicated in the instructions for use, concerning the correlation with ACTH IRMA technique (immuno-radiometric assay). This device is used for the quantitative determination of the ACTH (corticotropic hormone) concentrations in human plasma supplemented with EDTA on Nichols Advantage®. The company has directly notified the recipients of the offending lot by means of the attached message (26/05/2008) (11 KB) validated by AFSSaPS . The European Competent Authorities concerned are informed directly by the manufacturer. This information is intended for laboratory managers, health facility directors and reactive vigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

Nichols Advantage® ACTH
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    in-vitro_medical_device
  • Manufacturer
    DPC France

Manufacturer

DPC France
  • Source
    LAANSM