Device Recall Sysmex UF1000i Automated Urine Particle Analyzer with Urinalysis WAM

  • 모델명 / 제조번호(시리얼번호)
    Software versions 1.0, 1.01, 1.1.1, 1.1.2
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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

제조사

  • 제조사 주소
    Sysmex America, Inc., 1 Nelson C White Pkwy, Mundelein IL 60060-9528
  • 제조사 모회사 (2017)
  • Source
    USFDA