Devices

Device Recall Sysmex XN Series Automated Hematology Analyzers

  • 모델명 / 제조번호(시리얼번호)
    **Model: XN-10, Product Number: AP795756, Serial Numbers: 11001  29656, 29668-29786, 29788-29798, 29800-29801, 29803, 29804, 29807, 29812, 29816-29867  **Model: XN-11, Product Number: CS297931, Serial Numbers: A1001-A1124, A1127, A1130, A1135-A1140, A1142-A1144, A1146-A1149, A1151, A1153-A1159, A1161, A1163, A1171
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide, Canada
  • 제품 설명
    Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073 Japan
  • Manufacturer
    Sysmex America Inc
  • 1 Event

제조사

Sysmex America Inc
  • 제조사 주소
    Sysmex America Inc, 577 Aptakisic Rd, Lincolnshire IL 60069-4325
  • 제조사 모회사 (2017)
    Sysmex Corp.
  • Source
    USFDA