Device Recall FreeStyle

Fabricante

  • Dirección del fabricante
    Abbott Diabetes Care, Inc., 1360 S Loop Rd, Alameda CA 94502-7000
  • Source
    USFDA

12 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    All lot numbers beginning with R and all lot numbers T-G158-62981 and below are included.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    FreeStyle FLASH Blood Glucose Monitoring System; || Recalling Firm/Manufacturer: || Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
  • Manufacturer
  • Modelo / Serial
    For lot numbers beginning with A, B, C, D, G, H, K, and M, all lot numbers are included. All lot numbers from V-G157-31584 and below are included, and also all lot numbers Y-G018-32983 and below are included in the recall.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    FreeStyle Blood Glucose Monitoring System; || Recalling Firm/Manufacturer: || Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
  • Manufacturer
  • Modelo / Serial
    N/A. Product is a software package.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Software, distributed from website via clicking through an agrement to use only for informational purposes, and not as a substitute for professional medical advice treatment or diagnosis.
  • Descripción del producto
    FreeStyle CoPilot Web Based Data Management System, and FreeStyle CoPilot Health Management System,Versions 1 and 2. Web-based software system, no packaging.
  • Manufacturer
  • Modelo / Serial
    All lots, including: FC0010, FC0012, FC0013, FC0014, FC0015, FC0016, FC0017, FC0020, FC0019, FC0018, FC0021, FC0022, FC0023, FC0026, FC0024, FC0025, FC0027, FC0028, FC0029, FC0030, FC0031, FC0032, FC0033, FC0034, FC0036
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The product was released for distribution to 28 consignees in US. The recall was appropriately extended to the consumer/user level; i.e., the physicians and hospitals who received the recalled product. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.
  • Descripción del producto
    FreeStyle Connect Point of Care Blood Glucose Monitoring System, including Control Solutions and Test Strips; || Part Number: 70672-01; || Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
  • Manufacturer
  • Modelo / Serial
    Lot Numbers: 0522524, 0526329, 0526326, 0529324, 0532203, 0533607, 0533641, 0534362, 0534404, 0534421, 0601135, 0601165, 0601608, 0601661
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    The product was released for distribution to 28 consignees in US. The recall was appropriately extended to the consumer/user level; i.e., the physicians and hospitals who received the recalled product. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.
  • Descripción del producto
    FreeStyle Connect Blood Glucose Test Strips; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502; || Part Number: CAT70676-01
  • Manufacturer
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