Events

VIDAS AFP 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 BIOMERIEUX 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
    2003-07-29
  • 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-dm-div-vidas-afp-ref--30413-de-par-la-societe-biomerieux
  • 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 BIOMERIEUX withdraws from the market the batch 775364001 (per 13.04.04) of the in vitro diagnostic medical device called VIDAS AFP - reference 30413, following a problem of stability of one of the components of the cartridge-reagents resulting in a reduction of signal obtained with the cabinet calibrator and the possibility of out of standard low values ​​preventing the use of the device. A note. : the possibility of underestimation of patient results is 10% maximum over the entire period covering two recalibrations (ie 14 days). This device allows the determination of alpha-fetoprotein (AFP) in serum or plasma or amniotic fluid, on the VIDAS automaton.

Device

VIDAS AFP
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    in-vitro_medical_device
  • Manufacturer
    BIOMERIEUX

Manufacturer

BIOMERIEUX