Device Recall VITROS Chemistry Products VANC Reagent

  • Modelo / Serial
    Lot numbers: 31-5407 (exp. date 2017-05-23), 31-5474 (exp. date 2017-07-04), 31-5506 (exp. date 2017-07-04)
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution - US Distribution including Puerto Rico and to the countries of : Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Poland, Spain Singapore and Venezuela.
  • Descripción del producto
    VITROS Chemistry Products VANC Reagent, REF/Product Code 680 1709, Unique Identifier No. 10758750006731, Rx ONLY, IVD --- Ortho Clinical Diagnostics - USA -- Ortho-Clinical Diagnostics Pencoed, CF35 5PZ, UK ---- The VITROS VANC reagent is for ORTHO Clinical Diagnostics manufactured by Siemens. The VANC product has a maximum on-analyzer stability of < 7days. The on-analyzer stability of each VITROS VANC Reagent pack is determined by the system. Once the VANC reagent pack is loaded on the system, the on-analyzer stability time is continuously adjusted based upon both the amount of time the reagent pack is on the analyzer and the number of tests remaining in the pack. The method by which the on-analyzer stability of the VITROS VANC Reagent is determined is stated in the reagents Instructions for Use.
  • Manufacturer
  • 1 Event


  • Dirección del fabricante
    Ortho-Clinical Diagnostics, 100 Indigo Creek Dr, Rochester NY 14626-5101
  • Empresa matriz del fabricante (2017)
  • Source