Device Recall Sysmex UF1000i Automated Urine Particle Analyzer with Urinalysis WAM

  • Modèle / numéro de série
    Software versions 1.0, 1.01, 1.1.1, 1.1.2
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and the states of AL, AR, CA, CO, CT, FL, GA, HI, IA, IS, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX, VA, WA and WI and the country of Canada.
  • Description du dispositif
    The UF-1000i is a fully automated urine particle analyzer intended for vitro diagnostic use in urinalysis. The instrument can perform screening for abnormal samples with a high degree of accuracy, so it increases automation and efficiency in laboratories.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Sysmex America, Inc., 1 Nelson C White Pkwy, Mundelein IL 60060-9528
  • Société-mère du fabricant (2017)
  • Source
    USFDA