Device Recall SYNCHRON System(s) Rheumatoid Factor (RF) Reagent

  • Modelo / Serial
    Lot #M907325
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA including states of: AZ, CA, CO, IA, PA, NH, NV, NY, and WA; and countries of: Belgium, China, Czech Republic, France, Germany, Hong Kong, India, Italy, Japan, Kuwait, Lebanon, Lithuania, Mexico, Netherlands, Russian Federation, South Africa, Spain, Switzerland, Taiwan, Turkey, and United Kingdom.
  • Descripción del producto
    SYNCHRON System(s) Chemistry RF Rheumatoid Factor Part Number 475136 || RF reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems CAL 5 Plus, is intended for quantitative determination of Rheumatoid Factor concentration in human serum or plasma.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA