Device Recall VITROS (R) Chemistry Products FS Calibrator 1

  • Model / Serial
    Lots 91131 (exp. 07-Mar-2015) and 91241 (exp. 28-Feb-2016)
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    VITROS (R) Chemistry Products FS Calibrator 1, Product Code/ Catalog Number 6801873 -- For in vitro diagnostic use only --- VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate the VITROS 5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Ortho-Clinical Diagnostics, 1000 Lee Road, Rochester NY 14606
  • Manufacturer Parent Company (2017)
  • Source
    USFDA