Events

MRSA Agar 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 BIOMERIEUX 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
    2005-07-20
  • 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-gelose-mrsa-id-biomerieux
  • 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    On July 18, 2005, the company bioMérieux has withdrawn batches 795418401, 795204401, 794959301, 794783401, 794530501 from the in vitro diagnostic medical device called MRSA Agar ID reference 43451. This decision follows the possible decrease of the activity of the selective mixture used in the composition of this product. This decreased activity results in methicillin-sensitive Staphylococcus aureus strains exhibiting the growth and staining characteristics of methicillin-resistant Staphylococcus aureus. This device is a chromogenic culture medium for the detection and identification of methicillin-resistant Staphylococcus aureus (MRSA) from human specimens. The company has directly notified the recipients of the offending lots by means of the message. hereby validated (18/07/2005) (148 ko) by the Afssaps .. The competent European authorities concerned are informed directly by the manufacturer .. 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

MRSA Agar
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    in-vitro_medical_device
  • Manufacturer
    BIOMERIEUX

Manufacturer

BIOMERIEUX