Device Recall ROTROL P Contorl for ROTEM delta Thromboelastometry System

  • Modèle / numéro de série
    Lot 41925401
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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

Fabricant

  • Adresse du fabricant
    TEM Systems Inc, 3210 E Nc Hwy 54, Durham NC 27709
  • Société-mère du fabricant (2017)
  • Source
    USFDA