Device Recall Sysmex XE2100C Automated Hematology System

  • 모델명 / 제조번호(시리얼번호)
    catalog ##053-2311-4, all serial numbers
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution: USA including Puerto Rico.
  • 제품 설명
    Sysmex XE-2100C Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #053-2311-4 || The Sysmex XE-2100C is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories.
  • Manufacturer
  • 1 Event

제조사

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