Device Recall IL GEM PCL/PCL Plus Gem Test PT Cartridge

  • Modelo / Serial
    ID #: 6260030000.  Lot Numbers:  A1ILJPT001, H0ILJPT005, and K0ILJPT006.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: (USA) Nationwide Distribution including the countries of; Austria, Australia, Canada, Switzerland, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Hong Kong, Ireland, Israel, India, Italy, Korea, Liechtenstien, Libya, Netherlands, Norway, Oman,Portugal, Qatar, Saudi Arabia, Sweden, Turkey, Taiwan, and South Africa.
  • Descripción del producto
    IL GEM PCL/PCL Plus - Gem Test PT Cartridge || ITC-Nexus Dx || A unitized mlcrocoagulation test intended for use in performing one-stage prothrombin time.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    International Technidyne Corp., 68 Olsen Ave, Edison NJ 08820-2419
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA