Events

Retiro De Equipo (Recall) de Contour, Contour TS Blood Glucose Test Strips and Bonus Packs

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 Bayer Healthcare, LLC.

¿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
    59467
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3268-2011
  • Fecha de inicio del evento
    2011-08-12
  • Fecha de publicación del evento
    2011-09-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-07-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102842
  • 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
    Glucose dehydrogenase, glucose - Product Code LFR
  • Causa
    All 10- or 25- count glucose test strip vials, either loose vials or found in patient starter kits of contour, contour ts and contour" usb blood glucose meters are being recalled a packaging issue which, under certain conditions, can cause some test strips packaged in some small-count vials to operate outside of us fda-cleared performance specifications and produce a low-bias reading during blood.
  • Acción
    Bayer sent an "URGENT DIABETES TEST STRIP RECALL" letter dated August 12, 2011, to its customers with the name of the test strips, sizes recalled, reason for the recall, potential injury, and instructions to discontinue use and return the test strips to Bayer. The recall letter also included a recall response form that was to be faxed back to Bayer at 1-800-876-2243. For questions call Customer Logistics at 1-800-348-2637.

Device

Contour, Contour TS Blood Glucose Test Strips and Bonus Packs
  • Modelo / Serial
    9545C, 9677, 9678, 9679, 9680, 7151G, 7190, 7183, 9615, 7393, 9591, 9591A 9579, 1802, 6181, 7070A, 9725, 9507C, and 9578.   Contour 125 Count Bonus Pack (includes 2-50 Count and 1-25 Count Vials) the following lot numbers:DW0AC3B32A, DW0AC3B32C, DW0BC3B31A, DW0BC3B31B, DW0BC3D05B, DW0CC3B31A, DW0CC3B31B, DW0GC3B31C, DW0GC3B31D, DW0GC3B31F, DW0HC3B32A, DW9MC3B32D, DW9MC3B32E, DW9MC3B33A, and DW9MC3B33B.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution and Puerto Rico
  • Descripción del producto
    Contour, Contour TS Blood Glucose Test Strips and Bonus Packs || Intended for self-testing by people with diabetes and healthcare professionals to monitor glucose concentrations in whole blood
  • Manufacturer
    Bayer Healthcare, LLC

Manufacturer

Bayer Healthcare, LLC
  • Dirección del fabricante
    Bayer Healthcare, LLC, 430 S Beiger Street, Mishawaka IN 46544-3207
  • Empresa matriz del fabricante (2017)
    Bayer AG
  • Source
    USFDA