Events

Flex reagent cartridge CKMB Mass (MMB) 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
    2006-04-04
  • 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-cartouche-de-reactif-flex-ckmb-masse-mmb-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 April 3, 2006, the company Dade Behring withdrew from the market batches DE6347 (per 13/12/2006) and CG7003 (per 03/01/2007) of the in vitro diagnostic medical device called Flex reagent cartridge CKMB Mass (MMB) reference RF420. This device is a test to quantitatively measure the creatine kinase MB (CKMB) isoenzyme in human serum and plasma on the Dimension clinical chemistry system. This measure is motivated by quality control results that may have a negative bias of 19% to 45% and checks on patient samples have shown a negative bias of 15% to 25% that can occur with quality controls located in the expected values. The company has directly notified the recipients of the offending batches by means of the attached message (03/04/2006) (17 KB) validated by Afssaps. This information is intended for laboratory managers, the directors of health and to the correspondents of reactovigilance for diffusion, if necessary, to the services concerned.

Device

Flex reagent cartridge CKMB Mass (MMB)
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    in-vitro_medical_device
  • Manufacturer
    DADE BEHRING

Manufacturer

DADE BEHRING
  • Source
    LAANSM