Events

Alcohol Reagent (ETOH) 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
    2005-06-30
  • 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-reactif-alcool-etoh-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 June 28, 2005, Beckman Coulter SA withdrew from the market batches M407255 and M409024 of the in vitro diagnostic medical device called Alcohol Reagent (ETOH) reference 474947 following possible quality control out of limits and calibration discharges before their expiry date. In addition, the expiry dates of lots M412090 and M503108 of the same device are shortened by four months. This device is used with the SYNCHRON LX, the UniCel 600/800 system (s) and the SYNCHRON Systems ETOH Calibrator. It is intended for the quantitative determination of ethanol in serum, plasma, human urine or human whole blood. The company has directly notified the recipients of the offending lots by means of the attached message (30 / 06/2005) (28 kb) validated by Afssaps. The competent European authorities concerned 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

Alcohol Reagent (ETOH)
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    in-vitro_medical_device
  • Manufacturer
    BECKMAN COULTER

Manufacturer

BECKMAN COULTER