Device Recall COULTER DxH Cell Lyse

  • Modèle / numéro de série
    Lot Numbers: 0710001, 0710003, 0711002, 0712001, 0710002, 0710004, 0711001, 0711003, and  0712002.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- Australia, Belgium, Brunei Darussalam, Canada, France, Germany, Hong Kong, Hungary, India, Italy, Japan, Macao, Malaysia, Netherlands, Norway, Philippines, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and the United States.
  • Description du dispositif
    COULTER DxH Cell Lyse, Part number 628018(1L) and 628019 (5L). || The COULTER¿ DxH Cell Lyse is an erythrocyte lytic agent used for quantitative || determination of hemoglobin, enumeration of NRBC, and counting and sizing || leukocytes on UniCel¿ DxH 800 Coulter¿ Cellular Analysis System.
  • 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