Urgent Voluntary Recall of Some Nova Max® Test Strips, Meters

This press release is an announcement submitted by Nova Biomedical Diabetes Care, and was not written by Diabetes Health.

Aug 7, 2013

If you use Nova Max® blood glucose test strips or the Nova Max® PlusTM blood glucose monitoring system, this is to notify you that Nova Biomedical Diabetes Care (Nova Diabetes Care) is voluntarily recalling and replacing the indicated Nova Max glucose test strip lot numbers and unused Nova Max Plus glucose meter kits listed at www.novacares.com/news/additional-details-usa.php.

We have recently determined that some of the blood glucose test strips contained within the Nova Max glucose test strip lots listed in the link above may report a false, abnormally high blood glucose result. A false, abnormally high blood glucose result could, under certain conditions, lead to an insulin dosing error that could create a serious health risk requiring immediate medical attention. Nova Diabetes Care has decided to replace the Nova Max glucose test strips and Nova Max Plus glucose meter kits listed in the link above at no charge.

There are no other Nova Diabetes Care products or lot numbers impacted by this recall.

People with diabetes should immediately discontinue use of Nova Max glucose test strips from the indicated lot numbers. To receive replacement product at no charge, please follow the steps below:

Call Nova Diabetes Care Customer Service at 1-800-681-7390 to verify the Lot # for your Nova Max glucose test strips and Nova Max Plus Glucose Meter Kit, and confirm your mailing address so that we may ship you replacement product.

Please print and keep this notice with your Owner's Booklet. You may continue to test your blood glucose with your current blood glucose meter(s) using any other Nova Max glucose test strip lot not indicated as part of this recall while you wait for your replacement product to arrive.

While you wait for your replacement product to arrive, do not stop testing your blood glucose. In the event that you must use affected test strips from the lots indicated in the link above, Nova Diabetes Care recommends that you take the following precautions:

1) As stated in your Blood Glucose Monitor Owners Guide and Nova Max Glucose Test Strip Product Insert, perform a quality control solution test to confirm that your vial of Nova Max glucose test strips is working correctly. Do not use a test strip vial if control solution results are not within the expected range.

2) Verify all elevated blood glucose test results that are not consistent with your diabetes history by repeating the test using a new blood glucose test strip from a different vial (if available) or the same vial (if a new vial is unavailable).

3) Contact your healthcare provider immediately if your reported blood glucose result(s) are not consistent with your diabetes history, how you feel, or if you think your results are not accurate (higher than expected).

4) Never ignore symptoms or make significant changes to your diabetes management program without speaking to your health care professional.

People with diabetes should be aware of symptoms of high blood sugar (hyperglycemia) and low blood sugar (hypoglycemia). Contact your healthcare professional for advice on how to treat the symptoms noted below.

• Symptoms of high blood sugar include excessive thirst, excessive urination, blurred vision, weakness, nausea, vomiting, and abdominal pain.

• Symptoms of low blood sugar include trembling, excessive sweating, weakness, hunger, confusion, and headache. Some individuals may experience no symptoms before experiencing unconsciousness or seizures. It is important to treat low blood sugars promptly to avoid loss of consciousness or seizure.

 

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Categories: Nova Biomedical Diabetes Care, Nova Max Glucose Test Strips, Nova Max Plus Glucose Meters, Recall


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