Events

ImmunoComb II HCV IgG 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 INVERNESS MEDICAL 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
    2006-02-17
  • 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-immunocomb-ii-hcv-igg-inverness-medical-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 February 17, 2006, INVERNESS MEDICAL France withdrew lot 051102 from the in vitro diagnostic medical device called ImmunoComb II HCV IgG reference 60455002FR. This device is a rapid test for IgG antibodies against hepatitis C virus in human serum and plasma. This follows a demonstration of a drop in reagent stability that appears to affect the overall sensitivity of the kit with a risk of causing false negative results. The company has directly notified the recipients of the offending lot by means of the attached message (17/02/2006) (22 KB) validated by Afssaps. This message is completed by a letter Afssaps (17/02/2006) (18 ko) on the need to carry out the retest of all sera made negative, with this lot of reagent, using another reagent CE marked. The competent European authorities concerned are informed by Afssaps. This information is intended for laboratory managers, the directors of health establishments and the reactovigilance correspondents for dissemination, where appropriate, to the services concerned. Mail Inverness Medical France (17/02/2006) (22 KB Courrier Afssaps (17/02/2006) (18 KB)

Device

ImmunoComb II HCV IgG

Manufacturer

INVERNESS MEDICAL France
  • Source
    LAANSM