Device Recall UniCel CxH800 Coulter Cellular Analysis System

  • Modèle / numéro de série
    All Serial Numbers are affected.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Class 2 Recall - Worldwide Distribution -- USA, and the countries of : Canada, Australia, Macao, Belgium, Malaysia, Colombia, Myanmar, Croatia, Netherlands, Czech Republic, Norway, France, Philippines, Germany, Puerto Rico, Greece, Qatar,Hong Kong, Russian Federation, Hungary, Saudi Arabia, India, Singapore, Spain, Israel, taly Sweden, Japan, Switzerland, Korea, Turkey and United Kingdom.
  • Description du dispositif
    UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029. || The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a: (1) Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood; (2) Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial).
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • Société-mère du fabricant (2017)
  • Source
    USFDA