CLASS I Device recall · Reported 21 Aug 2013 · FDA Enforcement Report
Nova Max Plus Monitor System (Kit w/ Vials International) recalled
Nova Biomedical is recalling Nova Max Plus Monitor System (Kit w/ Vials International), 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
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-1906-2013
- 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
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 15 Jul 2013 | Recall initiated by company | |
| 9 Aug 2013 | Classified by FDA | +25 days |
| 21 Aug 2013 | Published 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 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
Where it was distributed
Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua
Questions about this recall
Why was it recalled?
Reports of false abnormally high glucose readings from test strips
Which lots are affected?
1010112059 12/31/2013 1010213171 04/30/2015 1010312066 12/31/2013 1010712339 10/31/2014
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 65617This 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.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Nova Max Glucose Test Strips Retail Canada) recalled by Nova Biomedical | Nova Biomedical | Other | Nationwide | |
| CLASS I | Nova Max Glucose Test Strips International recalled by Nova Biomedical | Nova Biomedical | Other | Nationwide | |
| CLASS I | Nova Max Glucose Test Strips Canada) recalled by Nova Biomedical | Nova Biomedical | Other | Nationwide | |
| CLASS I | Nova Max Glucose Test Strips Vials) recalled by Nova Biomedical | Nova Biomedical | Other | Nationwide | |
| CLASS I | Nova Max Plus Monitor System (Kit w/ Vials) recalled by Nova Biomedical | Nova Biomedical | Other | Nationwide | |
| CLASS I | Nova Max Plus Monitor System (Kit w/ Vials Canada) recalled | Nova Biomedical | Other | Nationwide | |
| CLASS I | Nova Max Glucose Test Strips DME) recalled by Nova Biomedical | Nova Biomedical | Other | Nationwide | |
| CLASS I | Nova Max Glucose Test Strips Boxed) recalled by Nova Biomedical | Nova Biomedical | Other | Nationwide | |
| CLASS I | Nova Max Glucose Test Strips Retail) recalled by Nova Biomedical | Nova Biomedical | Other | Nationwide |
More recalls from Nova Biomedical
All 25| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | ANNOUNCED | StatStrip Glucose Hospital Meter System recalled by Nova BiomedicalNova Biomedical StatStrip | Nova Biomedical | Device Malfunction | |
| Device | CLASS I | StatStrip Glucose Hospital Meter System recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |
| Device | CLASS I | StatStrip Glucose and B- Ketone meter recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |
| Device | CLASS I | StatStrip Glucose Hospital Meter System recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |
| Device | CLASS I | StatStrip Glucose and B- Ketone meter recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |
Other Insulin Pumps & Glucose Monitors recalls
All 468| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | The MiniMed Go app for iOS or MiniMed Go app recalled | Medtronic MiniMed | Device Malfunction | Nationwide |
| Device | CLASS II | MiniMed Flex Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Labeling Errors | Nationwide |
| Device | CLASS II | Fisher Scientific Sure-Vue Urine hCG Strip recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |
| Device | ANNOUNCED | StatStrip Glucose Hospital Meter System recalled by Nova BiomedicalNova Biomedical StatStrip | Nova Biomedical | Device Malfunction | |
| Device | CLASS I | StatStrip Glucose Hospital Meter System recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |