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

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

Nova Biomedical is recalling Nova Max Plus Monitor System (Kit w/ Vials Canada), 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 codes1010112073 10/31/2013 1010113002 03/31/2014 1010113008 03/31/2014 1010312097* 10/31/2013 1010512080** 10/31/2013
Quantity recalled28,240 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-1905-2013
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 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

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?

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

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) recalled by Nova BiomedicalNova 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

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DeviceCLASS IStatStrip Glucose Ketone (mmol/L) Hospital Meter System recalledNova BiomedicalDevice MalfunctionNationwide
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DeviceCLASS IINova Stat Profile Prime Plus POC Analyzer recalled by Nova BiomedicalNova BiomedicalDevice MalfunctionNationwide

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DeviceCLASS IIMiniMed Insulin Pump recalled by Medtronic MiniMedMedtronic MiniMedDevice MalfunctionCA
DeviceCLASS IOmnipod (Eros) Pod recalled by InsuletInsuletPackaging DefectsNationwide