Events

SIMPLASTIN;SIMPLASTIN EXCEL 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
    2005-08-16
  • 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-et-information-sur-les-reactifs-simplastin-et-simplastin-excel-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 August 11, 2005, following the detection of erroneous values ​​of the lndex of Sensibility International (ISI) in the record of these reagents, the company BioMérieux. has withdrawn lot 161711 from the market called SIMPLASTIN EXCEL (reference 252000 (6ml)) (expiry date 09/05). recommended to the users of the 19 batches of SIMPLASTIN EXCEL and SIMPLASTIN EXCEL S reagents mentioned in the attached mail, to take into account the new ISI values ​​redetermined for each batch of reagent / PLC, by the company BioMérieux, in order to calculate the International Normalized Ratio (INR) .. These devices are used for the determination of the Quick Time in human plasma. The time of Quick makes it possible to detect the abnormalities of the coagulation. The company directly warned the recipients of the incriminated batches by means of the attached message (11/08/2005) (30 ko) validated by the Afssaps. The European Competent Authorities concerned are informed directly by the manufacturer. This information is intended for laboratory managers, health facility directors and health-vigilance correspondents for dissemination, where appropriate, to the departments concerned. (26/08/2005) (16 KB) sent by the laboratory. The mail from the laboratory was modified on August 26, 2005: an error occurred in the mail of August 16, 2005, Ref: MTK / em - 078 Table A page 2 and Acknowledgment page 5.

Device

SIMPLASTIN;SIMPLASTIN EXCEL
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    in-vitro_medical_device
  • Manufacturer
    BIOMERIEUX

Manufacturer

BIOMERIEUX