Events

HercepTest Autostainer 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 DakoCytomation 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
    2005-10-13
  • 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-herceptest-autostainer-dakocytomation
  • 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 October 11, 2005, DakoCytomation withdrew from the market batches 00016965 and 00018107 of the in vitro diagnostic medical device called HercepTest Autostainer reference K5207 following the posibility of obtaining falsely reduced marking intensity. This device is used to the semi-quantitative immunocytochemical assay that determines the overexpression of the HER2 protein in breast cancer tissues. This dosage is indicated in the evaluation of the patients for whom treatment with Herceptin® is envisaged. The company directly informed the recipients of the incriminated batches by means of the attached message (13/10/2005) (18 KB) validated by AFSSAPS .. The relevant European Competent Authorities are informed directly by the manufacturer. This information is intended for laboratory managers, directors of health establishments and health-vigilance correspondents for the dissemination, where appropriate, of services. concerned.

Device

HercepTest Autostainer
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    in-vitro_medical_device
  • Manufacturer
    DakoCytomation

Manufacturer

DakoCytomation
  • Source
    LAANSM