Device Recall FreeStyle Flash Blood Glucose Monitors

  • Modèle / numéro de série
    Part number CAT11001-0; all serial numbers
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and countries of: Austria, Canada, Germany, Israel, Netherlands, Norway, Sweden, Switzerland, United Kingdom.
  • Description du dispositif
    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
  • 1 Event

Fabricant

  • Adresse du fabricant
    Abbott Diabetes Care, Inc., 1360 S Loop Rd, Alameda CA 94502-7000
  • Source
    USFDA

Un dispositif médical avec un nom similaire

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  • Modèle / numéro de série
    Catalog Number 17002 NDC 99073-0170-02. All serial numbers
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and countries of: Austria, Canada, Germany, Israel, Netherlands, Norway, Sweden, Switzerland, United Kingdom.
  • Description du dispositif
    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