Device Recall VITROS 350 Chemistry System

  • Modelo / Serial
    Software Version 9.4 and below; Serial Numbers J27000001 - 27004539
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution - US Nationwide including Puerto Rico, and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela
  • Descripción del producto
    VITROS 350 Chemistry System, Catalog Number 6802153, Unique Device Identifier Number 10758750002054; IVD. || Product Usage: || For in vitro diagnostic use. The VITROS 350 Chemistry System performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layered VITROS Slides.
  • Manufacturer
  • 1 Event


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