Device Recall VITROS Signal Reagent

  • Modelo / Serial
    Lots 8530 distributed to US customers and 1 Canadian customer (NOTE: Lot 8350 was distributed from Wales facility to non-US foreign customers.)
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Medical facilities nationwide and 1 foreign affiliate in Canada.
  • Descripción del producto
    VITROS Immunodiagnostic Products Signal Reagent, Catalog No. 107 2693 --- an in vitro diagnostic for use on the VITROS Immunodiagnostics ECi/ECiQ System, which is used to screen and diagnose more than 40 diseases and conditions including cardiac disease, hepatitis (A, B, or C), thyroid disorders, HIV, and pregnancy.
  • Manufacturer
  • 1 Event


  • Dirección del fabricante
    Ortho-Clinical Diagnostics, 100 Indigo Creek Drive, Rochester NY 14626
  • Source