CLASS I Device recall · Reported 21 Aug 2013 · FDA Enforcement Report
Nova Max Glucose Test Strips Boxed) recalled by Nova Biomedical
Nova Biomedical is recalling Nova Max Glucose Test Strips Boxed), 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-1899-2013
- 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 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
Where it was distributed
Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua
Questions about this recall
Is Nova Max Glucose Test Strips Boxed) recalled?
Yes. Nova Biomedical recalled Nova Max Glucose Test Strips Boxed) on 15 Jul 2013. The recall is Class I and its status is Terminated. Recall number Z-1899-2013.
Why was it recalled?
Reports of false abnormally high glucose readings from test strips
Which lots are affected?
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
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Nova Biomedical
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| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Lead & Heavy Metals | Nationwide |
| Device | CLASS I | Omnipod (Eros) Pod recalled by Insulet | Insulet | Lead & Heavy Metals | Nationwide |