Nova Diabetes Care is voluntarily recalling and replacing several lots of Nova Max Glucose Test Strips and unused Nova Max Plus Glucose Meter Kits. The Nova Max Test Strip lot numbers listed below have been recalled because some of the blood glucose test strips may report a false, abnormally high blood glucose result. A false, abnormally high blood glucose result could, under certain conditions, cause an insulin dosing error that could lead to a serious health risk requiring immediate medical attention.
Nova Max Test Strip Recalled Lots:
1020211346 1020212291 1020412341
1020211355 1020213043 1020512087
1020212032 1020213074 1020611348
1020212100 1020213109 1020712206
1020212101 1020411347 1020811350
1020212153 1020412255 1020912292
Several Nova Max Plus Meter Kits are also being recalled because they contain the recalled test strips. The glucose meters in these kits are not recalled and can be used with Nova Max Glucose Test Strips from a different lot that is not part of this recall. Patients with an unopened Nova Max Plus Meter Kit can find a list of recalled kit lot numbers on the Nova Diabetes Care website.
This recall does not affect any other brand of glucose meters or test strips.
For more information and to view the list of recalled Nova Max Plus Meter Kit lot numbers, please visit:
WHAT DOES THIS MEAN?
Please check your supply of diabetes test strips and see if you use Nova Max Glucose Test Strips. If you use Nova Max Glucose Test Strips, check the lot numbers and immediately stop using the Nova Max Glucose Test Strips from the recalled lot numbers.
To receive a replacement product at no charge, please call Nova Diabetes Care Customer Service at 1-800-681-7390 to verify the lot number for your Nova Max Glucose Test Strips and Nova Max Plus Glucose Meter Kit and provide your mailing address so that they may ship you replacement product.
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. If you do not have any other test strips that you can use, please consult your healthcare provider, pharmacist, or the Nova Diabetes Care website for advice: http://www.mediguard.org/r/0unpTl8sXxQM
This recall alert is also good reminder to be aware of the symptoms of high blood sugar (hyperglycemia) and low blood sugar (hypoglycemia). You should contact your healthcare provider right away for advice if you experience 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.
Healthcare providers and patients are encouraged to report side effects related to the use of medicines to the FDA's MedWatch program. You can reach MedWatch by:
—- Telephone: 1-800-332-1088
—- Fax: 1-800-332-0178
—- Mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
—- Website: www.fda.gov/medwatch
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