Events

Retiro De Equipo (Recall) de SIMPLASTIN;SIMPLASTIN EXCEL

Según L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en France que fue producido por BIOMERIEUX.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • Fecha
    2005-08-16
  • País del evento
    France
  • Fuente del evento
    ANSM
  • URL de la fuente del evento
    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
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Acción
    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 has withdrawn lot 161711 from the market called SIMPLASTIN EXCEL (reference 252000 (6ml)) (expiry date 09/05).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
  • Modelo / Serial
  • Descripción del producto
    in-vitro_medical_device
  • Manufacturer
    BIOMERIEUX

Manufacturer

BIOMERIEUX