Device Recall VITROS 5,1 FS System Software

  • Model / Serial
    Version 2.6.1 & Below
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Australia, New Zealand, Brazil, Canada, Chile, Argentina, Paraquay, Ecuador, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, UK, Northern Europe, France, Germany, Italy, Spain and Portugal.
  • Product Description
    VITROS 5,1 FS System Software || For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest.
  • Manufacturer
  • 1 Event

Manufacturer

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