Device Recall VITROS 3600 Chemistry System

  • Model / Serial
    Software Version 3.2 and below; Serial Numbers J36000012 - 36000879
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide Distribution - US Nationwide and the countries of Puerto Rico, and foreign distribution to: Argentina, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Israel, Italy, Japan, Kenya, Mexico, Panama, Philippines, Poland, Romania, Russia, Singapore, Spain, Taiwan, Turkey, and Venezuela.
  • Product Description
    VITROS 3600 Chemistry System, Catalog Number 6802783, Unique Device Identifier Number 10758750009930, Software Product Code 6802866, Software Version 3.2 and below; IVD. || Product Usage: || For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents.
  • Manufacturer
  • 1 Event


  • Manufacturer Address
    Ortho-Clinical Diagnostics, 100 Indigo Creek Dr, Rochester NY 14626-5101
  • Manufacturer Parent Company (2017)
  • Source