Device Recall COULTER Hematology Analyzers: LH 750; LH 500, and LH 780

  • Modèle / numéro de série
    Catalog Number(s): LH 750 System - 6605632, A85570, A68807; LH 780 System - 723585, A90728, A68808; LH 500 system - 6605525, 6605526, 6605527, A85566, A85564; All software versions
  • Classification du dispositif
  • Classe de dispositif
  • Dispositif implanté ?
  • Distribution
    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.
  • Description du dispositif
    Coulter LH 750, Coulter LH 780, and Coulter LH 500 Analyzers || Hematology Analyzers are quantitative, automated hematology analyzers and leukocyte differential counters For In Vitro Diagnostic used in clinical laboratories. They also provide automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids. The purpose of the LH 700 Series is to separate the normal patient, with all normal system-generated parameters, from the patient who needs additional studies of any of these parameters. These studies might include further measurements of cell size and platelet distribution, manual WBC differential or any other definitive test that helps diagnose the patients condition. The purpose of the LH 500 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, or any other test that aids in diagnosing an abnormality
  • Manufacturer
  • 1 Event


  • Adresse du fabricant
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • Société-mère du fabricant (2017)
  • Source