Several lots of Nova Max Glucose Test Strips used to test blood sugar levels are being recalled because they may report a false, abnormally high blood glucose result. This defect could, under certain conditions, result in an insulin dosing error that could lead to serious health risks requiring immediate medical attention.
The recall, initiated by Nova Diabetes Care, affects 21 lots of Nova Max Glucose Test Strips and Nova Max Plus glucose meter kits that include the test strips. The affected products were distributed both within and outside the continental USA. Nova Diabetes Care has notified all registered users, health care professionals, pharmacies and distributors where the Nova Max Glucose Test Strip and Nova Max Plus glucose meter kit are recommended or sold.
Individuals who use, recommend clinically, or sell Nova Max Glucose Test Strips for blood glucose testing should discontinue using or distributing the recalled products. To check or confirm which lots are involved in the recall, visit www.novacares.com/news/nova-max-recall.php or contact Nova Diabetes Care customer service at 1-800-681-7390.
People with Diabetes should be aware of symptoms of high blood sugar (hyperglycemia) and low blood sugar (hypoglycemia). Customers should contact their health care professional for advice on how to treat the symptoms.
Any adverse events or quality issues with this recall should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.