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

FDA: [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. Read more