Events

Reagents Vitros Immunodiagnostic Products / Prolactin Reagent Cartridge;Vitros immunodiagnostic Products / prolactin standards 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
    2000-08-11
  • 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-reactifs-denomme-vitros-immunodiagnostic-products-cartouche-de-reactifs-prolactine
  • 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
    Lot 90 (per 15.09.2000) of the reagent called Vitros Immunodiagnostic Products / prolactin reagent cartridge (reference 1849793) and batch 90 (per 15.09.2000) of the associated reagent called Vitros immunodiagnostic Products / prolactin standards (reference 1113596) of ORTHO-CLINICAL DIAGNOSTICS are withdrawn from the market due to the possibility of calibration failure.

Device

Reagents Vitros Immunodiagnostic Products / Prolactin Reagent Cartridge;Vitros immunodiagnostic P...

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS
  • Source
    LAANSM