Events

IMMULITE 2000 Testosterone Total 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 DPC France 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
    2006-01-10
  • 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-et-information-sur-un-lot-du-dmdiv-immulite-2000-testosterone-totale-dpc-france
  • 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 January 6, 2006, DPC France withdrew from the market part of lot 126 of the in vitro diagnostic medical device called IMMULITE 2000 Testosterone Total reference L2KTW. This device is used for the quantitative determination of total testosterone in serum with the IMMULITE 2000 analyzer. This decision is motivated by the fact that this lot contains a raw material that could interfere with the IMMULITE 2000 Estradiol assay (ref. L2KE2) thus causing an overestimation of the concentrations observed in Estradiol. Since the performance of lot 126 is not affected by this raw material, this recall only concerns recipients of the lot who use the IMMULITE 2000 assay on the same machine. estradiol. The company has directly notified all recipients of the offending lot by means of the message attached (06/01/2006) (134 KB) validated by Afssaps. The European Competent Authorities concerned are informed directly by the manufacturer. This information is intended for laboratory managers, health facility directors and reactive vigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

IMMULITE 2000 Testosterone Total
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    in-vitro_medical_device
  • Manufacturer
    DPC France

Manufacturer

DPC France
  • Source
    LAANSM