Device Recall Variant II Hemoglobin Testing System with CDM v 4.0

  • Model / Serial
    CDM version 4.0 software
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, Argentina, Australia, Brazil, Canada, China, Czech Republic, France, Germany, Hungary, India, Italy, Mexico, New Zealand, Singapore, South Korea, Sweden, Thailand, and the UK.
  • Product Description
    Bio-Rad Variant II Hemoglobin Testing System with CDM v 4.0, model number 270-2000, Manufactured by Bio-Rad Laboratories, Hercules, CA || Measurement of percent hemoglobin Alc is effective in monitoring long-term glucose control in individuals with diabetes mellitus.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Bio-Rad Laboratories Inc, 4000 Alfred Nobel Dr, Hercules CA 94547-1803
  • Source
    USFDA