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-de-lots-du-dmdiv-immulite-ace-dpc-france
  • 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 27, 2005, the company DPC France withdrew from the market lots 302 and 303 (per 31/08/05) in vitro diagnostic medical device called Immulite ACE reference LKCE1 following the detection of a defect in stability on these lots resulting in a significant decrease in the slope of the adjustments and, not systematically, in control values ​​outside the indicated areas. This device is used for quantitative determination of carcinoembryonic antigen (CEA) in serum, with the analyzer Immulite. This test is an aid in the follow-up of the cancers and in the establishment of a prognosis. The company directly warned the recipients of the incriminated lots by means of the attached message (27/05/2005) (10 ko) validated by AFSSaPS. The relevant European Competent Authorities 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 medical services. concerned.

Device

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

Manufacturer

DPC France
  • Source
    LAANSM