Reported Aug 21, 2013 · Terminated
Nova Max Plus Monitor System (Kit w/10 Count Vials) Catalog Number: 43435 Product usage: The Nova Max Glucose Test…
Nova Biomedical Corporation
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Nova Biomedical Corporation · 200 Prospect St · Waltham, MA · 02453
Is this the product you have?
- Nova Max Plus Monitor System (Kit
- w/10 Count Vials) Catalog Number43435
- Product usageThe 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 codes and dates
- Kit Lot/Exp
152 of 152 codes
101011200410/31/2013101011203810/31/2013101011210902/28/2014101011212102/28/2014101011215902/28/2014101011222805/31/2014101011228907/31/2014101011301609/30/2014101011305212/31/2014101011313412/31/2014101011317703/31/2015101021204610/31/2013101021210902/28/2014101021212112/31/2013101021214302/28/2014101021220603/31/2014101021222803/31/2014101021228907/31/2014101021235409/30/2014101021301609/30/2014101021305212/31/2014101021313409/30/2014101031201610/31/2013101031202510/31/2013101031204610/31/2013101031209502/28/2014101031212103/31/2014101031217103/31/2014101031218003/31/2014101031220703/31/2014
- Kit Lot/Exp
- Amount recalled
- 1,316,420 kits
This recall covers 10 products
The agency filed one notice per product. You are reading one of them; the other 9 are below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Reports of false abnormally high glucose readings from test strips
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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