FDAFDA · Alimentos y medicamentos·N.º oficial Z-1898-2013
Nova Max Glucose Test Strips (50 Count DME) Catalog Number: 43523 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control
Publicado el 21 de agosto de 2013 · Inicio del retiro: 15 de julio de 2013
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Reports of false abnormally high glucose readings from test strips
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Nova Biomedical Corporation
- Distribuidor
- Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua
- Lote
- Lot #/Exp.Date: 1010312046 10/31/2013 1020212032 02/28/2014 1020212100 04/30/2014 1020212101 04/30/2014 1020212153 06/30/2014 1020212207 07/31/2014 1020212291 10/31/2014 1020213074 03/31/2015 1020213109 04/30/2015 1020412255 09/30/2014 1020412341 12/31/2014 1020512087 03/31/2014 1020712206 07/31/2014 1020811350 12/31/2013 1020912292 10/31/2014
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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