Devices

ROTROL P

  • Model / Serial
    Article number 503-25 (US ROTROL P), Lot no. 41819801, exp date 2016-11 and Lot no. 41855701, exp date 2017-06.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH.
  • Manufacturer
    TEM Systems Inc
  • 1 Event

Manufacturer

TEM Systems Inc
  • Manufacturer Address
    TEM Systems Inc, 4309 Emperor Blvd Ste 100, Durham NC 27703-8069
  • Source
    USFDA

One device with a similar name

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Device Recall ROTROL P Contorl for ROTEM delta Thromboelastometry System
  • Model / Serial
    Lot 41925401
  • Product Classification
    Hematology and Pathology Devices
  • 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
    TEM Systems Inc