Device Recall COULTER HmX Hematology Analyzer

  • 모델명 / 제조번호(시리얼번호)
    Catalog Number(s): HMX CP - 178832, 178833, 178834, A91062, A90994; HmX AutoLoader - 6605522, 6605523, 6605524; All software versions.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) Internationally to Albania, Algeria, Andorra, Angola, Antigua and Barbuda, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bermuda, Bosnia and Herzegovina, Brazil, Bulgaria, Burundi, Canada, China, Colombia, Congo, Croatia, Czech republic, Ecuador, Egypt, Ethiopia, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, Iceland, india, Indonesia, Italy, Japan, Iraq, Jordan. Kenya, Kuwait, Libya, Lithuania, Macau, Lebanon, Macedonia, Malawi, Malaysia, Mexico, Mongolia, Morocco, Mozambique, Netherlands, New Zealand, Nigeria, Pakistan, Panama, Paraguay, Philippines, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Swaziland, Sweden, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, UAE, UK, Uruguay, Venezuela, Vietnam, Virgin Islands, Yemen, Zambia, Zimbabwe.
  • 제품 설명
    Coulter HmX CP and Coulter HmX AL Analyzers || The purpose of the HmX Hematology Analyzer is to separate the normal patient, with all normal system-generated parameters, from the patient who needs additional studies. These studies include further measurements of cell size and cell distribution, biochemical investigation or any other test that helps diagnose the abnormality
  • 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)
    All serial numbers.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- US, Algeria, Andorra, Antigua and Barbuda, Australia, Austria, Bahrain, Bangladesh, Bermuda, Bosnia and Herzegovina, Botswana, Brunei Darussalam, Bulgaria, Burkina Faso, Burundi, Canada, Cayman Islands, China, Congo, Cote d'Ivoire, Croatia, Czech Republic, Djibouti, Egypt, Finland, France, French Guiana, French Polynesia, Germany, Greece, Guadeloupe, Hong Kong, Iceland, India, Indonesia, Iraq, Italy, Japan, Jordan, Republic of Korea, Kuwait, Latvia, Lebanon, Libyan Arab, Jamahiriya, Lithuania, Macao, Malawi, Mexico, Mongolia, Morocco, Namibia, Netherlands, New Caledonia, New Zealand, Nigeria, Oman, Pakistan, Philippines, Poland, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Sri Lanka, Sudan, Swaziland, Switzerland, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, U.S. Virgin Islands, Yemen, and Zambia.
  • 제품 설명
    Coulter HmX Hematology Analyzer and HmX Hematology Analyzer with Autoloader. || Hematology Analyzers; Part Number: 6605522, 6605523, 6605524, 6605525, 6605526, 6605527, A85566, and A85564. || Quantitative, automated hematology analyzer and leukocyte differential cell || counter for In Vitro Diagnostic Use in clinical laboratories.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) and countries of: Canada, France, Germany, Italy, Spain, United Kingdom, and Singapore.
  • 제품 설명
    COULTER¿ HmX Hematology Analyzer || Part number: 6605522, 6605523, 6605524 || The COULTER HmX Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter for In Vitro Diagnostic Use in clinical laboratories.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) and countries of: Canada, France, Germany, Italy, Spain, United Kingdom, and Singapore.
  • 제품 설명
    COULTER¿ HmX Hematology Analyzer || with Autoloader || Part number: 6605525, 6605526, 6605527 || The COULTER HmX Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter for In Vitro Diagnostic Use in clinical laboratories.
  • Manufacturer