CLASS I Device recall · Reported 21 Aug 2013 · FDA Enforcement Report

Nova Max Plus Monitor System (Kit w/ Vials) recalled by Nova Biomedical

Nova Biomedical is recalling Nova Max Plus Monitor System (Kit w/ Vials), distributed nationwide in the US. The recall was initiated on 15 Jul 2013 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesKit 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
Quantity recalled1,316,420 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-1903-2013
FDA event ID
65617
Recalling firm
Nova Biomedical, Waltham, MA
Classification
Class I
Status
Terminated
Recall initiated
15 Jul 2013
FDA classified
9 Aug 2013
Reported
21 Aug 2013
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Other Reasons

Timeline

15 Jul 2013Recall initiated by company
9 Aug 2013Classified by FDA+25 days
21 Aug 2013Published in enforcement report+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Reports of false abnormally high glucose readings from test strips

Product as listed by the FDA

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

Where it was distributed

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

Nationwide

Questions about this recall

Why was it recalled?

Reports of false abnormally high glucose readings from test strips

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

9 other products · FDA event 65617

This product is part of a recall event; the main page for the event is Nova Max Glucose Test Strips Retail Canada) recalled by Nova Biomedical.

ReportedClassRecallCompanyReasonWhere
CLASS INova Max Glucose Test Strips Retail Canada) recalled by Nova BiomedicalNova BiomedicalOtherNationwide
CLASS INova Max Glucose Test Strips International recalled by Nova BiomedicalNova BiomedicalOtherNationwide
CLASS INova Max Glucose Test Strips Canada) recalled by Nova BiomedicalNova BiomedicalOtherNationwide
CLASS INova Max Plus Monitor System (Kit w/ Vials International) recalledNova BiomedicalOtherNationwide
CLASS INova Max Glucose Test Strips Vials) recalled by Nova BiomedicalNova BiomedicalOtherNationwide
CLASS INova Max Plus Monitor System (Kit w/ Vials Canada) recalledNova BiomedicalOtherNationwide
CLASS INova Max Glucose Test Strips DME) recalled by Nova BiomedicalNova BiomedicalOtherNationwide
CLASS INova Max Glucose Test Strips Boxed) recalled by Nova BiomedicalNova BiomedicalOtherNationwide
CLASS INova Max Glucose Test Strips Retail) recalled by Nova BiomedicalNova BiomedicalOtherNationwide

More recalls from Nova Biomedical

All 25
ReportedClassRecallCompanyReasonWhere
DeviceANNOUNCEDStatStrip Glucose Hospital Meter System recalled by Nova BiomedicalNova Biomedical StatStripNova BiomedicalDevice Malfunction
DeviceCLASS IStatStrip Glucose Hospital Meter System recalled by Nova BiomedicalNova BiomedicalDevice MalfunctionNationwide
DeviceCLASS IStatStrip Glucose and B- Ketone meter recalled by Nova BiomedicalNova BiomedicalDevice MalfunctionNationwide
DeviceCLASS IStatStrip Glucose Hospital Meter System recalled by Nova BiomedicalNova BiomedicalDevice MalfunctionNationwide
DeviceCLASS IStatStrip Glucose and B- Ketone meter recalled by Nova BiomedicalNova BiomedicalDevice MalfunctionNationwide

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DeviceCLASS IIFisher Scientific Sure-Vue Urine hCG Strip recalled by Alere San DiegoAlere San DiegoPotency & AssayNationwide
DeviceANNOUNCEDStatStrip Glucose Hospital Meter System recalled by Nova BiomedicalNova Biomedical StatStripNova BiomedicalDevice Malfunction
DeviceCLASS IStatStrip Glucose Hospital Meter System recalled by Nova BiomedicalNova BiomedicalDevice MalfunctionNationwide