Devices

Device Recall Freestyle Flash

  • Model / Serial
    All lot numbers beginning with R and all lot numbers T-G158-62981 and below are included.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Approximately 10,005,206 meters have been distributed worldwide since 1999, with 5,885,332 meters distributed in the US, and 4,517,211 in use.
  • Product Description
    FreeStyle FLASH Blood Glucose Monitoring System; || Recalling Firm/Manufacturer: || Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
  • Manufacturer
    Abbott Laboratories Medisense Products
  • 1 Event

Manufacturer

Abbott Laboratories Medisense Products
  • Manufacturer Address
    Abbott Laboratories Medisense Products, 1360 S Loop Rd, Alameda CA 94502-7000
  • Source
    USFDA

3 devices with a similar name

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Device Recall FreeStyle Flash
  • Model / Serial
    All codes.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide
  • Product Description
    Abbott brand FreeStyle Flash Blood Glucose Meter, distributed by Abbott Diabetes Care, 1420 Harbor Bay Pwky. || Alameda, CA 94502. Manufactured by: || Flextronics International, Long Jing Industrial Estate, Long Jing Road, Xi Li Town, Nantou District, Shenzhen, China
  • Manufacturer
    Abbott Diabetes Care, Inc.
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.
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.