Events

Disposable Tips 1000 μl with filter 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 TECAN 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-de-lots-du-dmdiv-disposable-tips-1000-l-with-filter-tecan
  • 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 17/11/2005, TECAN informed Afssaps of the withdrawal of lots U122098L-1325, U122098L-3225 and U122098L-2325 from the in vitro diagnostic medical device called Disposable Tips 1000 μl with filter reference 612 513.1. These are tips for Tecan Genesis .. reagents / sample dispensers. This measurement follows the discovery of a tip defect (presence of two filters instead of one) that may cause reactive sampling problems. / sample resulting in false negative or positive results. The company notified the users directly on 17/11/2005, by means of the attached message (25/11/2005) (16 KB). users, no tip of the aforementioned lots was used in the context of a diagnosis. Therefore, this withdrawal does not require patient-specific measures. The relevant European Competent Authorities are informed directly by the manufacturer. This information is intended for laboratory managers, the directors of health establishments and health and safety correspondents. dissemination, where appropriate, to the services concerned.

Device

Disposable Tips 1000 μl with filter
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    in-vitro_medical_device
  • Manufacturer
    TECAN

Manufacturer

TECAN
  • Source
    LAANSM