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Nova Max Glucose Test Strips: Recall - May Report False, Abnormally High Blood Glucose Result

[Posted 07/29/2013]

AUDIENCE: Consumer, Family Physician, Pharmacy

ISSUE: Nova Diabetes Care initiated a voluntary recall of 21 lots of the Nova Max Glucose Test Strips distributed both in the USA and outside the continental USA. Nova Max Plus glucose meter kits that include test strips from the recalled lots are also included in this voluntary recall.

The company has recently determined that some of the blood glucose test strips contained within the indicated Nova Max Glucose Test Strip lots and Nova Max Plus glucose meter kits may report a false, abnormally high blood glucose result. A false abnormally high blood glucose result could, under certain conditions, result in an insulin dosing error that could lead to a serious health risk requiring immediate medical attention.

BACKGROUND: Upon identifying the issue, Nova Diabetes Care promptly 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.

RECOMMENDATION: Those who use, recommend clinically, or sell Nova Max Glucose Test Strips for blood glucose testing should immediately discontinue using or distributing glucose test strips from the recalled lots (see the Recall Notice for a listing of recalled lots).

Customers can check to confirm if they have blood glucose test strips from the affected lots on the attached list, by visiting www.novacares.com/news/nova-max-recall.php or by contacting 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 healthcare professional for advice on how to treat the symptoms.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[07/26/2013 - Press Release - Nova Diabetes Care]

Page Last Updated: 07/29/2013
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http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm362932.htm