Events

Retiro De Equipo (Recall) de Device Recall Nova StatStrip Glucose Test Strips

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 Nova Biomedical Corporation.

¿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
    64638
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1154-2013
  • Fecha de inicio del evento
    2013-02-25
  • Fecha de publicación del evento
    2013-04-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-09-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116761
  • 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 oxidase, glucose - Product Code CGA
  • Causa
    Glucose test strips reports no result message when tested.
  • Acción
    The firm, Nova Biomedical, sent an "Urgent Field Safety Notice 01-13SS" dated March 18, 2013 and US customers notification by phone contact and to the International customers including a Faxback Form to be communicated to and sent to Nova Biomedical Subsidiary by two methods of delivery (Email and Phone Call). The customers were instructed to INVALIDATE the Nova StatStrip Glucose Test Strip lots indicated in the list on all StatStrip meters within your institute; REPLACE all Nova StatStrip Glucose Test Strips from the indicated lots with replacement test strips provided by Nova; REMOVE all unused boxes of the Nova StatStrip Glucose Test Strip lots indicated from all locations within your institute; RETURN all unused boxes of the Nova StatStrip Glucose Test Strips lots indicated to Nova Biomedical U.K. or your local Nova distributor following the country specific instructions provided by your authorized Nova representative, and complete and return the Fax-Back Form via email or FAX to your Regional Service Manager at 781-8914806. On April 08, 2013, the firm expanded the recall notification to include one additional test strip lot #0313021309 which was shipped under two catalog numbers(Catalog # 42214 and Catalog# 51493). US Notification by phone contact with key customer contact facilitated by Senior Manger of Technical Support Services. International - Field Safety Notice and Faxback Form is being communicated to and sent to Nova Biomedical Subsidiary by two methods of delivery (Email and Phone Call). Questions regarding this notice should be directed to the following Nova Biomedical EU Authorized Representative at: Nova Biomedical Innovation House, Aston Lane South Runcorn,WA7 3FY Telephone: + 44 1244 287087 Email: Europe@novabiomedical.co.uk. or US at (781) 894-0800.

Device

Device Recall Nova StatStrip Glucose Test Strips
  • Modelo / Serial
    Lot 0312361309, Expires 6/30/2015 Expanded recall: Lot 0313021309, Expires 07/31/2015
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) including states of: CA, IL, KY,NY, WV and countries of: United Kingdom and Italy.
  • Descripción del producto
    Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) || Catalog # 51493 (UK Only)
  • Manufacturer
    Nova Biomedical Corporation

Manufacturer

Nova Biomedical Corporation
  • Dirección del fabricante
    Nova Biomedical Corporation, 200 Prospect St, Waltham MA 02453
  • Empresa matriz del fabricante (2017)
    Nova Biomedical Corporation
  • Source
    USFDA