Devices

Device Recall Nova Max Glucose Test Strips

Modèle / numéro de série
Kit Lot/Exp: 1010112004 10/31/2013 1010112038 10/31/2013 1010112109 02/28/2014 1010112121 02/28/2014 1010112159 02/28/2014 1010112228 05/31/2014 1010112289 07/31/2014 1010113016 09/30/2014 1010113052 12/31/2014 1010113134 12/31/2014 1010113177 03/31/2015 1010212046 10/31/2013 1010212109 02/28/2014 1010212121 12/31/2013 1010212143 02/28/2014 1010212206 03/31/2014 1010212228 03/31/2014 1010212289 07/31/2014 1010212354 09/30/2014 1010213016 09/30/2014 1010213052 12/31/2014 1010213134 09/30/2014 1010312016 10/31/2013 1010312025 10/31/2013 1010312046 10/31/2013 1010312095 02/28/2014 1010312121 03/31/2014 1010312171 03/31/2014 1010312180 03/31/2014 1010312207 03/31/2014 1010312228 05/31/2014 1010312262 06/30/2014 1010312289 07/31/2014 1010312312 09/30/2014 1010312354 09/30/2014 1010313016 09/30/2014 1010313052 12/31/2014 1010313101 12/31/2014 1010313128 01/31/2015 1010313134 01/31/2015 1010411355 10/31/2013 1010412016 10/31/2013 1010412046 10/31/2013 1010412066 10/31/2013 1010412093 12/31/2013 1010412095 10/31/2013 1010412121 03/31/2014 1010412262 03/31/2014 1010412312 09/30/2014 1010413101 01/31/2015 1010413134 01/31/2015 1010413171 04/30/2015 1010512016 10/31/2013 1010512095 12/31/2013 1010512157 03/31/2014 1010512212 03/31/2014 1010512262 07/31/2014 1010512269 07/31/2014 1010512312 09/30/2014 1010513085 12/31/2014 1010513101 01/31/2015 1010513171 04/30/2015 1010612095 02/28/2014 1010612157 03/31/2014 1010612262 07/31/2014 1010612312 07/31/2014 1010612339 09/30/2014 1010613085 10/31/2014 1010613171 04/30/2015 1010712157 03/31/2014 1010712262 07/31/2014 1010713079 12/31/2014 1010713085 12/31/2014 1010813085 12/31/2014 1010912254 05/31/2014 1011113007 09/30/2014
Classification du dispositif
Clinical Chemistry and Clinical Toxicology Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua
Description du dispositif
Nova Max Plus Monitor System (Kit w/10 Count Vials) || Catalog Number: 43435 || 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
Manufacturer
Nova Biomedical Corporation
1 Event
- Rappel de Device Recall Nova Max Glucose Test Strips

Fabricant

Nova Biomedical Corporation

Adresse du fabricant
Nova Biomedical Corporation, 200 Prospect St, Waltham MA 02453
Société-mère du fabricant (2017)
Nova Biomedical Corporation
Source
USFDA

9 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

Device Recall Nova Max Glucose Test Strips

Modèle / numéro de série
Lot #/Exp.Date: 1010211346 12/31/2013 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 1020411347 12/31/2013 1020412255 09/30/2014 1020412341 12/31/2014 1020512087 03/31/2014 1020611348 12/31/2013 1020712206 07/31/2014 1020811350 12/31/2013
Classification du dispositif
Clinical Chemistry and Clinical Toxicology Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua
Description du dispositif
Nova Max Glucose Test Strips (50 Count Retail) || Catalog Number: 43437 || 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
Manufacturer
Nova Biomedical Corporation

Device Recall Nova Max Glucose Test Strips

Modèle / numéro de série
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
Classification du dispositif
Clinical Chemistry and Clinical Toxicology Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua
Description du dispositif
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
Manufacturer
Nova Biomedical Corporation

Device Recall Nova Max Glucose Test Strips

Modèle / numéro de série
Lot #/Exp.Date: 1020211355 12/31/2013 1020212032 02/28/2014 1020212207 07/31/2014 1020212291 10/31/2014 1020213043 02/28/2015 1020213109 04/30/2015 1020412255 09/30/2014 1020412341 12/31/2014 1020512087 03/31/2014 1020811350 12/31/2013
Classification du dispositif
Clinical Chemistry and Clinical Toxicology Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua
Description du dispositif
Nova Max Glucose Test Strips (10 Count Boxed) || Catalog Number: 43590 || 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
Manufacturer
Nova Biomedical Corporation

Device Recall Nova Max Glucose Test Strips

Modèle / numéro de série
Lot #/Exp.Date: 1020212032 02/28/2014 1020212100 04/30/2014 1020212153 06/30/2014 1020212207 07/31/2014 1020213074 03/31/2015 1020412341 12/31/2014 1020912292 10/31/2014
Classification du dispositif
Clinical Chemistry and Clinical Toxicology Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua
Description du dispositif
Nova Max Glucose Test Strips (100 Count Retail Canada)Catalog Number: 43955 || 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
Manufacturer
Nova Biomedical Corporation

Device Recall Nova Max Glucose Test Strips

Modèle / numéro de série
Lot #/Exp.Date: 1020212032 02/28/2014 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 1020811350 12/31/2013 102121304 02/28/2015
Classification du dispositif
Clinical Chemistry and Clinical Toxicology Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua
Description du dispositif
Nova Max Glucose Test Strips (10 Count Vials) || Catalog Number: 43604 || These strips are kitted into Nova Max Glucose Test Strip System Kits 43435 and 45507 || 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
Manufacturer
Nova Biomedical Corporation

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