Device Recall VITROS (R) Chemistry Products Calibrator Kit 17

  • Modelo / Serial
    Lots 1732 (exp. 31-Jul-2014), 1743 (exp. 31-Jul-2014), 1753 (exp. 28-Feb-2015), 1764 (31-Jul-2015)
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (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 (R) Chemistry Products Calibrator Kit 17, Product Code/ Catalog Number 6801701 -- For in vitro diagnostic use only --- VITROS Chemistry Products Calibrator Kit 17 is used in conjunction with VITROS Chemistry Products FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System for the quantitative measurement of C-reactive protein (CRP) using VITROS hsCRP Reagent.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Ortho-Clinical Diagnostics, 1000 Lee Road, Rochester NY 14606
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA