Devices

Device Recall FreeStyle Flash Blood Glucose Monitors

  • Model / Serial
    Part number CAT11001-0; all serial numbers
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and countries of: Austria, Canada, Germany, Israel, Netherlands, Norway, Sweden, Switzerland, United Kingdom.
  • Product Description
    FreeStyle Blood Glucose Monitors System. || For in vitro diagnostic use only. Store at room || temperature below 86 degrees F (30 degrees C). Use test strips || only within the system operating temperature || range as outlined in your Owner's Booklet. || Meter made in China; || Distributed by Abbott Diabetes Care, Alameda, CA || The FreeStyle mete should only be used with FreeStyle Test Strips and FreeStyle Control Solution. Using other brands of test strips and control solutions with the FreeStyle Mete can product inaccurate results. || The FreeStyle Glucose meter is incorporated into the OmniPod insulin Management system (manufactured by Insulet Corporation, Bedford, MA and is intended for subcutaneous delivery of insulin. || Intended to monitor blood glucose from samples taken from the body. IVD use only,
  • Manufacturer
    Abbott Diabetes Care, Inc.
  • 1 Event

Manufacturer

Abbott Diabetes Care, Inc.
  • Manufacturer Address
    Abbott Diabetes Care, Inc., 1360 S Loop Rd, Alameda CA 94502-7000
  • Source
    USFDA

One device with a similar name

Learn more about the data here

Device Recall FreeStyle Flash Blood Glucose Monitors
  • Model / Serial
    Catalog Number 17002 NDC 99073-0170-02. All serial numbers
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and countries of: Austria, Canada, Germany, Israel, Netherlands, Norway, Sweden, Switzerland, United Kingdom.
  • Product Description
    FreeStyle Flash Blood Glucose Monitors System. || Meter made in China; || Distributed by TheraSense, Alameda, CA || The FreeStyle Flash meter should only be used with FreeStyle Test Strips and FreeStyle Control Solution. Using other brands of test strips and control solutions with the FreeStyle Meter can product inaccurate results. || Intended to monitor blood glucose from samples taken from the body. IVD use only,
  • Manufacturer
    Abbott Diabetes Care, Inc.