Events

CLINITEK 50 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 BAYER 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
    2003-05-27
  • 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-quelques-analyseurs-clinitek-50-par-bayer-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
    The company BAYER Diagnostics withdraws from the market the serial numbers between 168252 and 168292 of the in vitro diagnostic medical device called: CLINITEK 50, urinary chemistry analyzers (reference: 00566193). In fact, some analyzers may have malfunctions (error code) or give erroneous results if they are connected to mains without earth connection. The CLINITEK 50 analyzer, in combination with reagent strips, allows the semi-quantitative determination, in the urine, of the following parameters: nitrite, pH, density, bilirubin, urobilinogen, glucose, ketone bodies, proteins, microalbumin, leucocytes, blood .. The users concerned were contacted directly.

Device

CLINITEK 50
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    in-vitro_medical_device
  • Manufacturer
    BAYER DIAGNOSTICS

Manufacturer

BAYER DIAGNOSTICS
  • 제조사 모회사 (2017)
    Bayer AG
  • Source
    LAANSM