Events

AMPLICOR HPV Amplification 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 Roche Diagnostics 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
    2005-04-11
  • 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-kit-amplicor-hpv-amplification-roche-diagnostics
  • 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 April 6, 2005, the company ROCHE Diagnostics withdrew from the market lot F09579 of the medical device for in vitro diagnostic called Kit AMPLICOR HPV Amplification reference 3610799190 following. the possibility of obtaining more frequent ß-globin Optical Density results for the positive control, leading to the invalidation of the series. the theoretical possibility that a sample with a very low HPV titre may give a negative result even though the series has been validated by the positive control. This device is used for the detection of high-risk human papillomavirus (HPV) DNA genotypes in clinical specimens (cervical cells taken in liquid medium). The company has directly notified the recipients of the offending lot by means of the message. attached (06/04/2005) (78 ko) validated by the Afssaps .. The competent European authorities concerned are informed directly by the manufacturer. This information is intended for laboratory managers, the directors of health and to the correspondents of reactovigilance for diffusion, if necessary, to the services concerned.

Device

AMPLICOR HPV Amplification
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    in-vitro_medical_device
  • Manufacturer
    Roche Diagnostics

Manufacturer

Roche Diagnostics