Events

Capillary Adapters 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 Radiometer SA 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
    2005-07-01
  • 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-lots-du-dmdiv-adaptateurs-pour-capillaires-radiometer-sa
  • 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 June 29, 2005, Radiometer SA withdrew from the market the batches included between lot 041643 inclusive and lot 045124 inclusive, of the in vitro diagnostic medical device called capillary adapters, reference 906-018. This decision follows a manufacturing defect of the adapter that fits poorly on the capillary and on the suction probe causing air suction that mixed with the sample leads to a bias on the parameter results pO2 .. This device is used with analyzers ABL 5 and BPH 5 .. The company has directly notified the recipients of the incriminated lots by means of the message attached (29/06/2005) (40 KB) validated by Afssaps .. The relevant European Competent Authorities 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

Capillary Adapters
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    in-vitro_medical_device
  • Manufacturer
    Radiometer SA

Manufacturer

Radiometer SA
  • Source
    LAANSM