Events

Dimension® PBNP Calibrator 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 Dade-Behring 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
    2005-11-25
  • 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-calibrateur-dimension-r-pbnp-dade-behring
  • 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 24/11/2005, the company Dade-Behring withdrew from the market lot 5FD038 (per 01/06/2006) of the in vitro diagnostic medical device called Calibrator Dimension® PBNP reference RC423. This device is a calibrator for the calibration of the PBNP method, for the quantitative determination of the N-terminal proBNP (natriuretic peptide type B) in human plasma on the Dimension® clinical chemistry system. A previous withdrawal dated November 3, 2005 occurred on lot 5BD009 for a stability defect of the PBNP Calibrator resulting in a positive bias on the quality control values ​​after recalibration and as a consequence an overestimation of the patient results. Following this previous withdrawal and new reports, the validity of the Calibrator before opening has been redefined at 5 months and therefore lot 5FD038 has reached this new validity limit. The company has directly notified the recipients of the offending lot by means of the attached message (24/11/2005) (19 KB) validated by Afssaps. The relevant European Competent Authorities are informed directly by the competent authority of the United Kingdom, MHRA .. This information is intended for laboratory managers, directors of health establishments and reactive vigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

Dimension® PBNP Calibrator
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    in-vitro_medical_device
  • Manufacturer
    Dade-Behring

Manufacturer

Dade-Behring
  • Source
    LAANSM