Events

BETATOP UR5 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 ALL DIAG 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
    2006-02-20
  • 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-betatop-ur5-all-diag
  • 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, ALL DIAG withdrew from the market lot 165D11 (per 12/2006) of the in vitro diagnostic medical device called BETATOP UR5 reference 5401 following two reports reporting false-negative results of detection of ß- hCG in the serum .. The company has directly notified the recipients of the offending batch by means of the message attached (17/02/2006) (12 KB) validated by Afssaps, supplemented by a letter Afssaps (17/02 / 2006) (26 kb) on the modalities to be followed for patients who would have been tested negative for ß-hCG with this lot. This information is intended for laboratory managers, the directors of health establishments and correspondents of reactive vigilance for diffusion, if necessary, with the services concerned .. Courrier All Diag (17/02/2006) (12 ko Courrier Afssaps ( 17/02/2006) (26 KB)

Device

BETATOP UR5
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    in-vitro_medical_device
  • Manufacturer
    ALL DIAG

Manufacturer

ALL DIAG
  • 제조사 모회사 (2017)
    Biosynex
  • Source
    LAANSM