Events

Elecsys 2010 assay tips 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 Roche Diagnostics 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
    2005-11-15
  • 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-elecsys-2010-assay-tips-roche-diagnostics
  • 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 November 10, 2005, the company ROCHE Diagnostics removed from the market the batch 05053110 of the in vitro diagnostic medical device called Elecsys 2010 assay tips reference 11706799 following the possibility that some tips of this lot can be plugged because of a mold of This fault leads either to an error message 58 S without result, or to values ​​that are too high or too low, all of which are respectively accompanied by alarms 51 or 50 on the Elecsys analyzer 2010. The company has directly notified the recipients of the offending lot by means of the attached message (10/11/2005) (50 KB) validated by Afssaps. The European competent authorities concerned are informed directly by the manufacturer. address to the laboratory managers, the directors of the health establishments and the reactovigilance correspondents for diffusion, if necessary, to the services concerned.

Device

Elecsys 2010 assay tips
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    in-vitro_medical_device
  • Manufacturer
    Roche Diagnostics

Manufacturer

Roche Diagnostics