Events

Pastorex Toxo 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 Bio-Rad 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
    2003-08-28
  • 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-dmdiv-pastorex-toxo-ref--72724-de-par-la-societe-bio-rad
  • 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 BIO-RAD withdraws from the market lot 3G0158 (per 15.06.04) of the in vitro diagnostic medical device called Pastorex Toxo - reference 72724, following the observation of a significant increase in non-specific results, due to a increased sensitivity of the latex used for this batch. This device makes it possible to detect anti-Toxoplasma gondii antibodies in the serum by an agglutination test of latex particles. This defect does not entail any risk of erroneous patient results since the negative control is also concerned and since any positive result must be confirmed - as mentioned in the leaflet - by another technique allowing to specify the class and the title of the antibodies.

Device

Pastorex Toxo
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    in-vitro_medical_device
  • Manufacturer
    Bio-Rad

Manufacturer

Bio-Rad