Events

FusionQuant® Kit m-bcr 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 IPSOGEN SAS 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
    2005-11-30
  • 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-fusionquant-r-kit-m-bcr-ipsogen-sas
  • 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 29/11/2005, the company IPSOGEN SAS withdrew the lot 05-04-01 (per 03/2006) from the in vitro diagnostic medical device called FusionQuant® Kit m-bcr reference FQPP-09-CE. This device is used for real-time Quantitative PCR analysis of the m-bcr Transcript in bone marrow or peripheral blood samples of patients with Acute Lymphocytic Leukemia or Ph-positive Chronic Myeloid Leukemia. m-bcr fusion has already been diagnosed. This measure follows the discovery of a defect in the stability of this batch resulting in the production of a standard ABL curve (for the control gene). ABL) having an upper slope and intercept in absolute value than the reference values, this invalidating the series of assays. The company has directly notified the recipients of the offending batch by means of the attached message (29/11/2005) (25 KB) validated by Afssaps. This information is intended for laboratory managers, the directors of establishments health and to the correspondents of reactovigilance for diffusion, if necessary, to the services concerned.

Device

FusionQuant® Kit m-bcr
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    in-vitro_medical_device
  • Manufacturer
    IPSOGEN SAS

Manufacturer

IPSOGEN SAS
  • Source
    LAANSM