Events

DUOMICRO 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 DIAGAST 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
    2004-06-14
  • 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-2-lots-du-dmdiv-duomicro-ref-79750-de-par-diagast
  • 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 DIAGAST withdraws from the market batches 303000 and 304000 (March 2005) of the in vitro diagnostic medical device called DUOMICRO - reference 79750 (ready-to-use reagents in microplate for ABO-RH grouping and RH-K phenotyping), following reports of decreased activity of anti-e (RH5) / clones MS16 + MS63 leading to false negative results for e (RH5) antigen. This device corresponds to microplates of 96 U-bottom wells in which pre-deposited and pre-dried reagents (monoclonal antibodies, negative control) were taken; it makes it possible to determine the presence of erythrocyte antigens A and / or B, D (RH1), C (RH2), E (RH3), c (RH4), e (RH5) and K (KEL1) on the surface of red blood cells. to note: the investigations carried out so far by the laboratory Quality Control Diagast, did not lead to the reproduction of these anomalies.

Device

DUOMICRO
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    in-vitro_medical_device
  • Manufacturer
    DIAGAST

Manufacturer

DIAGAST