Events

VITROS Immunodiagnostic Products / CA 15-3 reagent cartridge 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 Ortho-Clinical 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
    2004-03-10
  • 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-vitros-ca-15-3-de-par-ortho-clinical-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
    Ortho-Clinical Diagnostics is withdrawing lot 635 (exp 19.05.04) from the market for the in vitro diagnostic medical device called VITROS Immunodiagnostic Products / CA 15-3 reagent cartridge - reference 680 0039, following the presence, in a few cartridges, a vial of non-compliant conjugated reagent, leading to calibration failures or to results 95% lower than those expected for patient samples and quality controls (invalidation of the assay series). This device is used on the Vitros ECI analyzer for the determination of the CA 15-3 marker (Cancer Antigen 15-3) in human serum and plasma (EDTA or heparin); marker associated with human breast tumors.

Device

VITROS Immunodiagnostic Products / CA 15-3 reagent cartridge

Manufacturer

Ortho-Clinical Diagnostics