Device Recall The NucliSENS easyMAG Magnetic Silica

  • Modelo / Serial
    Reference number: 280133, Lot numbers: Z017KA1MS, Z017KB1MS, Z017LE1MS, Z017MA1MS, Z017NA1MS, Z017NB1MS, Z017NC1MS and Z017ND1MS.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution. US Nationwide; BioMerieux Subsidiaries in: Argentina, Austria, Australia, Brazil, Canada, Switzerland, Chile, Colombia, Czech republic, Germany, Spain, France United Kingdom, Greece, China, Hungary, India, Italy, Japan, South Korea, Netherlands, Poland, Portugal, Russia Fed., Sweden, Singapore, Thailand, Turkey, South Africa; Distributors in: Peru, Kenya, Morocco, Serbia, Romania, Uruguay, Latvia, Dutch Antilles, Israel, Georgia, Armenia, Malaysia, Belarus and Direct Customers in: Togo, Djibouti, Burkina Faso, Mongolia, Zimbabwe, Uganda and Iraq.
  • Descripción del producto
    MagSIL (NucliSENS easyMAG Magnetic Silica), || Product Usage: || The NucliSENS¿ easyMAG¿ system is an in vitro diagnostic medical device and is intended for the automated isolation (purification and concentration) of total nucleic acids (RNA/DNA) from biological specimens.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    BioMerieux SA, Chemin De L'Orme, Marcy L'Etoile France
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA