Device Recall COULTER GENS

  • 모델명 / 제조번호(시리얼번호)
    part number: 6605381, 6605381R, 6605381U
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) and countries including: Algeria, Andorra, Angola, Antigua and Barbuda, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bermuda, Bulgaria, Burundi, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Ethiopia, France, Germany, Greece, Guadeloupe, Guam, Guatemala, Hong Kong, Iceland, India, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Macao, Malaysia, Mayotte, Mexico, Monaco, Morrocco, Myanmar, Namibia, Netherlands, 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, Vietnam, and Virgin Islands (US).
  • 제품 설명
    Coulter GEN's || 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 LH500 Analyzer also provides a semi-automated reticulocyte analysis.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
  • 제조사 모회사 (2017)
  • Source
    USFDA