Events

TPHA kit 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 EUROBIO 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
    2003-10-06
  • 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-kit-tpha-ref-shasyp00-8t-de-par-eurobio
  • 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
    Eurobio withdraws 604465 (January 01, 2005) from the market for the in vitro diagnostic medical device known as: TPHA kit - reference SHASYP00-8T, following the presence of agglutinates in certain test red cell suspension vials, resulting in loss of sensitivity that can lead to false negative results. As a precautionary measure, in agreement with Afssaps, Eurobio asks biologists to reconsider all syphilis serodiagnostics concerned by this batch (present on the French market since September 10, 2003). A note. : in the case of a negative test, the notice advises to complete the profile of the results by practicing a RPR / VDRL-Coal on the sample. This device allows the detection and the titration of the antibodies anti-Treponema pallidum within the framework serodiagnosis of syphilis.

Device

TPHA kit
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    in-vitro_medical_device
  • Manufacturer
    EUROBIO

Manufacturer

EUROBIO
  • Source
    LAANSM