Events

Vitros Immunodiagnostic Products / IgM anti-VHA standard 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
    2000-05-23
  • 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-de-reactif-denomme-vitros-immunodiagnostic-products-etalon-igm-anti-vha
  • 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 60 of the reagent called Vitros Immunodiagnostic Products / IgM anti-VHA standard (reference 1372101) from the company ORTHO CLINICAL DIAGNOSTICS is withdrawn from the market due to a risk of lowering the signal that may cause a rise in the values ​​of the controls beyond the specifications and elevation of values ​​of patient samples. As a result, from the date of expiration of the calibration curve that has been validated by control values ​​in accordance with those expected after use of the standard control protocol, lot 60 of the reagent called Vitros Immunodiagnostic Products / cartridge IgM anti-HAV reagent (reference 8450124), mandatory for use with the former, is also withdrawn from the market.

Device

Vitros Immunodiagnostic Products / IgM anti-VHA standard

Manufacturer

ORTHO CLINICAL DIAGNOSTICS