Events

Anti-ADENOVIRUS GROUPE (except ADV-8) / clone BIO-11 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 ARGENE BIOSOFT 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
    2003-01-16
  • 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-dispositif-div-denomme-anti-adenovirus-groupe-excepte-adv-8-clone-bio-11-ref-11-021-14-021-par-la-societe-argene-biosoft
  • 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
    ARGENE BIOSOFT withdraws from the market the batch G2206 (per 06.03) of the in vitro diagnostic medical device called Anti-ADENOVIRUS GROUPE (except ADV-8) / clone BIO-11 / references 11-021 and 14-021, following the detection of a decrease of sensitivity with respect to types 2 and 12 of Adenovirus. This device is used for the detection of Adenoviruses in infected cells obtained from samples of secretions and cells of the respiratory tracts or after isolation on cell cultures ...

Device

Anti-ADENOVIRUS GROUPE (except ADV-8) / clone BIO-11
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    in-vitro_medical_device
  • Manufacturer
    ARGENE BIOSOFT

Manufacturer

ARGENE BIOSOFT
  • Source
    LAANSM