Device Recall ROTROL P Contorl for ROTEM delta Thromboelastometry System

  • Model / Serial
    Lot 41925401
  • Product Classification
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    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

Manufacturer

  • Manufacturer Address
    TEM Systems Inc, 3210 E Nc Hwy 54, Durham NC 27709
  • Manufacturer Parent Company (2017)
  • Source
    USFDA