Events

Retiro De Equipo (Recall) de Device Recall FreeStyle Connect

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Abbott Diabetes Care, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    34665
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0604-06
  • Fecha de inicio del evento
    2006-02-17
  • Fecha de publicación del evento
    2006-03-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-01-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44396
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    System, Test, Blood Glucose, Over The Counter - Product Code NBW
  • Causa
    The device may give inaccurate elevated blood glucose test results. this may lead to over treatment and hypoglycemic complications may result.
  • Acción
    On 2/17/06 the firm initiated the recall via its reps and on 2/22/06 notification was via letters explaining the reason for the recall and reporting that its reps will replace the units.

Device

Device Recall FreeStyle Connect
  • 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
    Clinical Chemistry and Clinical Toxicology Devices
  • 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
    Abbott Diabetes Care, Inc.

Manufacturer

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