Events

VITROS® AFP;VITROS® CA 19-9 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 Ortho-Clinical 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
    2004-11-04
  • 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-vitros-ca-19-9-de-par-ortho-clinical-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 November 3, 2004, Ortho-Clinical Diagnostics removed lot 660 (per 28.01.05) from the in vitro diagnostic medical device called VITROS® AFP - reference 192 5551 and lot 670 (per 07.12.04). ) of the in vitro diagnostic medical device known as VITROS® CA 19-9 - reference 680 0040, following the finding of results inferior to those expected; this anomaly is due to the production of a light signal lower than that expected by some wells. The company Ortho-Clinical Diagnostics has directly informed the recipients of the incriminated lots by means of the message attached (03/11/2004) ( 22 kb). The competent authorities have been notified directly by the manufacturer. This information is addressed to the directors of health establishments and correspondents of réactovigilance for diffusion, if necessary, with the services concerned.

Device

VITROS® AFP;VITROS® CA 19-9

Manufacturer

Ortho-Clinical Diagnostics