Lot Numbers: 4207225241 and 4207261241

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide Distribution, including the state of NY

Nova - EZ CHEM Control Solution P/N 9612, Nova Biomedical, Waltham, MA 02454

Serial Numbers: 39000207226 39000207229 39000207256 39000207270 39000307226 39000307229 39000307256 39000307270 39000407229 39000407270 39000507226 39000507229 39000507270 39000607229 39000607270 39000707229 39000707270 39000807226 39000807229 39000907270 39001007229 39001007256 39001007270 39001107229 39001107256 39001107270 39001207256 39001207270 39001307256 39001307270 39001407256 39001407270 39001507256 39001507270 39001607256 39001607270 39001707256 39001707270 39001807256 39001807270 39001907256 39001907270 39002007256 39002007270 39002107256 39002107270 39002207256 39002207270 39002307256 39002307270 39002407256 39002407270 39002507256 39002507270 39002607256 39002707256 39002907256 39003007256 39003107256 39003207256 39003307256 39006207249 39006307249 39006407249 39006507249 39006607249 39006607263 39006707249 39006707263 39006807249 39006807263 39006907249 39006907263 39007007263 39007107263 39007207263 39007307249 39007407249 39007507249 39007807249 39007907249 39008007249 39008107249 39008207249 39008307249 39008407249 39008507249 39008607249 39009607263 39009707263 39009807263 39009907263 39010007263 39010507275 39010607275 39010707275 39010807275 39010907275 39011007275 39011107275 39011207275 39011507275 39011607275 39011707275 39011807275 39011907275 39012007275 39012107275 39012307275 39012807275 39012907275 39013007275 39013207275 39013307275 39013407275 39013507275 39013607275 39013707275 39013807275 39013907275 39014107275 39014207275 39014307275 39014407275 39014507275 39014607275 39014707275 39014807275 39014907275 39015007275 39015107275 39015207275 39015307275

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide Distribution, including the state of NY

Nova - EZ CHEM Creatinine Meter: SRS Versions 5.1 and 5.2 || P/N 9600, Nova Biomedical, Waltham, MA 02454

1010112059 12/31/2013 1010213171 04/30/2015 1010312066 12/31/2013 1010712339 10/31/2014

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua

Nova Max Plus Monitor System (Kit w/10 Count Vials International) || Catalog Number: 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

1010112073 10/31/2013 1010113002 03/31/2014 1010113008 03/31/2014 1010312097* 10/31/2013 1010512080** 10/31/2013

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua

Nova Max Plus Monitor System (Kit w/10 Count Vials Canada) Catalog Number: 43861 || 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

1020211350 12/31/2013

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua

Nova Max Glucose Test Strips (10 Count Canada)Catalog Number: 43877 || Product 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

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

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua

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

Lot #/Exp.Date: 1020112086 03/31/2014 1020212032 02/28/2014 1020213074 03/31/2015 1020213109 04/30/2015

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua

Nova Max Glucose Test Strips (50 Count International || Catalog Number: 45512 || 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

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

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua

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

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

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua

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

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

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua

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

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

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua

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

Nova Biomedical: Stat Profile Prime

see letter | all

IVD: Blood gas analyser IVD, point-of-care

46827

IVD: Blood glucose analyser

15265, 37271, 45172

IVD: Calcium electrode, Magnesium electrode

15264, 27813, 37272, 42458

IVD: Calcium electrode, Magnesium electrode

Model Catalog: 47116 (Lot serial: all lots); Model Catalog: 44052 (Lot serial: all lots); Model Catalog: 46766 (Lot serial: all lots)

StatStrip Meter System

Model Catalog: 35238 (Lot serial: 806721)

CCX Creatinine Membrane Kit

Model Catalog: (Lot serial: SOFTWARE VERSION 4.08)

STAT PROFILE CCX ANALYZERS

Model Catalog: 20394 (Lot serial: )

STAT PROFILE M MG++ SENSOR

Model Catalog: 41509 (Lot serial: )

Statstrip Glucose Hospital Meter

Model Catalog: 43861 (Lot serial: 1010112073); Model Catalog: 43861 (Lot serial: 1010113002); Model Catalog: 43861 (Lot serial: 1010113008); Model Catalog: 43877 (Lot serial: 1020212032); Model Catalog: 43955 (Lot serial: 1020212032); Model Catalog: 43955 (Lot serial: 1020212207); Model Catalog: 43877 (Lot serial: 1020211355); Model Catalog: 43955 (Lot serial: 1020211355); Model Catalog: 43877 (Lot serial: 1020212153); Model Catalog: 43955 (Lot serial: 1020212153); Model Catalog: 43877 (Lot serial: 1020213074); Model Catalog: 43955 (Lot serial: 1020213074); Model Catalog: 43877 (Lot serial: 1020412341); Model Catalog: 43955 (Lot serial: 1020412341); Model Catalog: 43877 (Lot serial: 1020912292); Model Catalog: 43955 (Lot serial: 1020912292); Model Catalog: 43877 (Lot serial: 1020212100); Model Catalog: 43955 (Lot serial: 1020212100); Model Catalog: 43877 (Lot serial: 1020212207)

NOVA MAX PLUS BLOOD GLUCOSE MONITORING SYSTEM

Model Catalog: 15196 (Lot serial: 707222); Model Catalog: 15196 (Lot serial: 610333); Model Catalog: 15196 (Lot serial: 701034); Model Catalog: 15196 (Lot serial: 704053)

Nova 8 Calibrator Pack

Model Catalog: 42214 (Lot serial: lot #: 0313021309)

NOVA STATSTRIP GLUCOSE TEST STRIPS