Device Recall UniCel DxH 600 Coulter Cellular Analysis System

Manufacturer

  • Manufacturer Address
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

3 devices with a similar name

Learn more about the data here

  • Model / Serial
    all serial numbers Part No. 775222
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and Internationally to Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Brunei Darussalam, Canada, China, Colombia, Croatia, Czech Republic, Ecuador, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Republic of Korea, Kuwait, Lebanon, Lithuania, Macao, Malaysia, Mayotte, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Norway, Oman, Panama Philippines, Poland, Portugal, Puerto Rico , Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Republic, United Kingdom, Uruguay, and Vietnam.
  • Product Description
    UniCel DxH 600 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 775222 || The UniCel DxH 800/DxH 600 analyzers are quantitative, multi-parameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found in clinical laboratories. The DxH 800 is available as an analyzer for use on a benchtop or with a floor stand. The DxH 600 is available as an analyzer for use on a benchtop only.
  • Manufacturer
  • Model / Serial
    all serial numbers Part No. B23858
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and Internationally to Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Brunei Darussalam, Canada, China, Colombia, Croatia, Czech Republic, Ecuador, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Republic of Korea, Kuwait, Lebanon, Lithuania, Macao, Malaysia, Mayotte, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Norway, Oman, Panama Philippines, Poland, Portugal, Puerto Rico , Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Republic, United Kingdom, Uruguay, and Vietnam.
  • Product Description
    UniCel DxH 600 Coulter Cellular Analysis System, Software Version 1.1.1.0, Part No. B23858 || The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear.
  • Manufacturer
  • Model / Serial
    All serial numbers
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, Canada, Australia, China, Belgium, Brunei Darssalam, Colombia, Croatia, Czech Republic, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kuwait, Macao, Malaysia, Mexico, Myanmar, Netherlands, New Zealand, Norway, Oman, Philippines, Poland, Panama, Portugal, Puerto Rico, Qatar, Romania, Russia Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, and Vietnam.
  • Product Description
    UniCel DxH 600 Coulter Cellular Analysis System, Part No. B23858. || Used for in vitro diagnostic use in screening patient populations found in clinical laboratories.
  • Manufacturer