Events

Reagent B27-FITC / B7-PE 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 BECKMAN COULTER 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
    2005-07-25
  • 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-reactif-b27-fitc-b7-pe-de-beckman-coulter
  • 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 22 July 2005, Beckman Coulter withdrew from the market lot 6 (expiry 01/08/2007) of the in vitro diagnostic medical device called reagent B27-FITC / B7-PE, reference A07739 following the implementation of Evidence of variations in performance from one vial to another may be the source of false positive results. This device is used to demonstrate the expression of HLA-B27 antigen on leukocytes. This highlighting assists in the diagnosis of ankylosing spondylitis. The company Beckman Coulter directly warned the recipients of the offending batch by means of the attached message (22/07/2005) (23 KB) validated by the Afssaps . The competent European authorities concerned are informed directly by the manufacturer. This information is intended for medical biology laboratory managers, health facility directors and reactive vigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

Reagent B27-FITC / B7-PE
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    in-vitro_medical_device
  • Manufacturer
    BECKMAN COULTER

Manufacturer

BECKMAN COULTER