Events

OneTouch GlucoTouch Plus Blood Glucose Meters 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 LifeScan 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
    2005-09-19
  • 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-lecteur-onetouch-r-glucotouch-r-plus-lifescan
  • 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
    In agreement with Afssaps, LifeScan is recalling OneTouch GlucoTouch Plus Blood Glucose Meters (L4266RBxxx Series to L5048RBxxx). Segments may be missing from the display and may result in an error in the reading of the result. Pharmacists in health facilities and / or pharmacies with these serial numbers should contact LifeScan on 0800 459 459 to inform them of the procedure to be followed. .. In addition, pharmacists are also asked to display in their dispensary the recall of devices mentioned and to inform users by means of the attached document (19/09/2005) (43 KB) which contains recommendations as well as the Verification of the display instructions. The relevant European Competent Authorities shall be informed directly by the manufacturer.

Device

OneTouch GlucoTouch Plus Blood Glucose Meters
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    in-vitro_medical_device
  • Manufacturer
    LifeScan

Manufacturer

LifeScan