Events

CAPILLARYS IMMUNOTYPING 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 SEBIA 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
    2005-04-01
  • 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-capillarys-immunotyping-sebia
  • 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 29 March 2005, SEBIA withdrew from the market batches 28064/01, 28064/02, 28064/03, 28064/04 of the in vitro diagnostic medical device CAPILLARYS IMMUNOTYPING reference 2100 following the identification of the specificity of a lot of anti-Ig M used, which can lead to an erroneous diagnosis of biclonal gammapathy when there is only one monoclonal immunoglobulin .. This device is used for the detection and characterization of monoclonal proteins ( immunotyping) in human serum by capillary electrophoresis in the automatic system CAPILLARYS .. The company has directly notified the recipients of the offending lots by means of the message attached (29/03/2005) (63 KB) validated by Afssaps. This information is intended for laboratory managers, the directors of health establishments and the reactovigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

CAPILLARYS IMMUNOTYPING
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    in-vitro_medical_device
  • Manufacturer
    SEBIA

Manufacturer

SEBIA
  • Source
    LAANSM