Device Recall ROTROL P Contorl for ROTEM delta Thromboelastometry System

  • Modelo / Serial
    Lot 41925401
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed in the states of AZ, AR, CA, FL, GA, HI, ID, IL, IN, LA, MD, MA, MN, MO, NE, NJ, NM, NY, PA, OH, SC, SD, TN, TX, UT, WA, WV and the country of Germany.
  • Descripción del producto
    ROTROL P Control for ROTEM delta Thromboelastometry System, For In Vitro Diagnostic Use Only. Quality control material for monitoring accuracy and precision of test carried out on the ROTEM delta Thromboelastometry System.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    TEM Systems Inc, 3210 E Nc Hwy 54, Durham NC 27709
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA