Events

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
    2003-04-04
  • 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-des-dispositifs-simplastin-excel-et-simplastin-excel-s-de-la-societe-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
    The BIOMERIEUX company withdraws from the market. the lots 161506 (per.28.07.03); 161639 (per .28.07.04); 161716 (per .28.02.05); 161717 (per. 28.04.05) of the in vitro diagnostic medical device called: SIMPLASTIN EXCEL S - ref. 252182 (10X6ml). lots 161503 (per.28.06.03); 161504 (per .8.09.03); 161554 (per.28.11.03); 161640 (per.28.08.04); 161664 (per.28.01.05) of the in vitro diagnostic medical device called: SIMPLASTIN EXCEL S - ref. 252183 (5x20ml). lots 161659 (per27.07.05); 161711 (per.28.09.05) of the in vitro diagnostic medical device called: SIMPLASTIN EXCEL - ref. 252000 (10x6ml). the lots 161403 (per.28.07.03); 161480 (per .28.09.03); 161509 (per .28.12.03); 161510 (28.02.04); 161552 (March 28.03.04); 161586 (per .8.08.04); 161596 (per .28.01.05); 161660 (per .28.05.05) of the in vitro diagnostic medical device called: SIMPLASTIN EXCEL - ref. Because of their heterogeneity, abnormally long Quick * (TQ) times are obtained from certain vials. Therefore, if the TQ of the test plasma is made using a different vial than the one used to determine the Control TQ, the calculation of the INR (International Standardized Report) may be overestimated (elevation greater than 0.3) and lead to misinterpretation. * The time of Quick (TQ) explores all the factors of the extrinsic pathway of coagulation.

Device

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

Manufacturer

BIOMERIEUX