Events

Genscreen Plus HIV Ag-Ab 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 Bio-Rad 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
    2005-06-28
  • 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-du-dmdiv-genscreen-plus-hiv-ag-ab-bio-rad
  • 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 June 24, 2005, Bio-Rad removed the lot from the market. 4M0051 (per 30/05/2006). 4L0576 (per 15/04/2006). 4L1576 (per 15/04/2006). 4L0577 (per 30/04/2006). 5A0578 (30/05/2006). 5B0579 (per 15/06/2006) of the in vitro diagnostic medical device known as Genscreen Plus HIV Ag-Ab references 72375 and 72376 .. This decision follows the possible instability of the conjugate R6 (polyclonal antibodies of sheep biotinylated anti-p24 HIV1) of the kit, resulting in positive HIV Ag control values ​​below the cut-off, thereby invalidating the assay series Previously, this possibility of instability led to the removal of lot 4L0575 on February 25, 200. .. This device is a kit for the detection of HIV infections in human serum / plasma by enzyme immunoassay technique. The company has directly notified the recipients of the incriminated batches by means of the attached message (24/06/2005 ) (17 ko) validated by Afssaps. This information is intended for laboratory managers, health facility directors and reactive vigilance correspondents for dissemination, where appropriate, to patients. concerned.

Device

Genscreen Plus HIV Ag-Ab
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    in-vitro_medical_device
  • Manufacturer
    Bio-Rad

Manufacturer

Bio-Rad