Events

ACCESS® AFP 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 BECKMAN COULTER 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
    2004-10-07
  • 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-access-afp-de-par-beckman-coulter
  • 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
    The company Beckman Coulter withdraws from the market batches 415515 (per.30.09.05), 416251 and 416781 (per 31.10.05) of the in vitro diagnostic medical device called ACCESS® AFP - reference 33210, following the formation of a precipitates blocking agents present in the reagent, which may result in undervalued quality control results, outside the acceptance ranges. It was found that this only affected the results of samples with an alpha-fetoprotein (AFP) concentration of less than 18 ng / ml. The Beckman Coulter company has directly informed the recipients of these batches. This information is intended for directors and correspondents of reactive vigilance for dissemination, where appropriate, to the services concerned.

Device

ACCESS® AFP
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    in-vitro_medical_device
  • Manufacturer
    BECKMAN COULTER

Manufacturer

BECKMAN COULTER