Events

Retiro De Equipo (Recall) de Device Recall AccuCheK Inform II Blood Glucose Monitor

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 Roche Diagnostics Operations, 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
    64460
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1113-2013
  • Fecha de inicio del evento
    2013-03-06
  • Fecha de publicación del evento
    2013-04-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116419
  • 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
    Roche investigation into complaints found accu-chek inform ii and coaguchek xs pro system barcode reading meters had the potential of intermittent erroneous decoding of patient identification if barcodes being read fail to meet size and/or quality standards.
  • Acción
    Consignees of both devices were notified by Urgent Medical Device Correction letters sent via UPS Ground (receipt required) beginning 3/06/2013. The notice contained recommendation not to use EAN-13 barcode system and ensure barcodes used meet quality standards; use operator and patient lists (downloaded from a data manager) in order to check any decoded identification against the respective list. The notice directed forwarding of the notice if the product was further distributed. Customers were asked to complete the attached fax form. Contact the Customer Care Service Center, 24 hours a day, seven days a week at 1-800-440-3638 for Accu check questions and 1-800-428-4674 for CoaguChek questions about the information contained in this UMDC.

Device

Device Recall AccuCheK Inform II Blood Glucose Monitor
  • Modelo / Serial
    part number 05060311001, 05060303001
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner. || Used with the ACCU-CHEK Inform II System to quantitatively measure glucose (sugar).
  • Manufacturer
    Roche Diagnostics Operations, Inc.

Manufacturer

Roche Diagnostics Operations, Inc.
  • Dirección del fabricante
    Roche Diagnostics Operations, Inc., 9115 Hague Rd, Indianapolis IN 46256-1025
  • Empresa matriz del fabricante (2017)
    Roche Holding AG
  • Source
    USFDA