Device Recall COULTER LH 500 Series System

  • 모델명 / 제조번호(시리얼번호)
    Not available.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) including the Virgin Islands and the countries of Algeria Andorra Angola Antigua and Barbuda Argentina Australia Bahrain Bangladesh Belgium Bermuda Brazil Bulgaria Burundi Cameroon Canada Chile China Colombia Croatia Czech Republic Denmark Ecuador Egypt Ethiopia France Germany Greece Guadeloupe Guam Guatemala Honduras Hong Kong Hungary Iceland India Indonesia Iraq Ireland Israel Italy Japan Jordan Korea, Republic of Kuwait Latvia Lebanon Libyan Arab Jamahiriya Lithuania Macao Malaysia Mayotte Mexico Monaco Morocco Myanmar Namibia Netherlands New Zealand Norway Oman Pakistan Panama Philippines Poland Puerto Rico Qatar Reunion Romania Russian Federation Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sri Lanka Sweden Switzerland Taiwan Thailand Trinidad and Tobago Tunisia Turkey United Arab Emirates United Kingdom Uruguay Venezuela Viet Nam Yemen Zimbabwe
  • 제품 설명
    COULTER LH 500 Series System , || part number: LH500 System Help 2A4.103271; || LH 500 Series System 100V, PN 178832; || LH 500 Series System 120V, PN 178833; || LH 500 Series System 240V, PN 178834; || LH 500 Series System Remanufactured (115V), PN A91062; || LH 500 Series System Remanufactured (220V), PN A90994 || SW Version 2A4, 2A5. || Serial Number: all. || The COULTER LH 500 Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter For In Vitro Diagnostic Use in clinical laboratories. The LH 500 Analyzer also provides a semi-automated reticulocyte analysis.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • 제조사 모회사 (2017)
  • Source
    USFDA

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  • 모델명 / 제조번호(시리얼번호)
    Product LH500 100V Part number 178832; Product LH500 120V Part number 178833; Product LH500 240V Part Number 178834; All Serial Numbers.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed Nationwide and Canada.
  • 제품 설명
    Coulter¿ LH 500 Series System. Beckman Coulter, Inc. Brea, CA. || Quantitative, automated hematology analyzer and leukocyte differential cell counter for in vitro diagnostic use in clinical laboratories.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    All serial Numbers.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Throughout the United States and Canada
  • 제품 설명
    COULTER LH 500 Series System
  • Manufacturer