The Food and Drug Administration is warning patients with diabetes about a recall of up to 62 million glucose test strips used to measure blood sugar levels that can show incorrect, abnormally high blood sugar readings.
Nova Diabetes Care announced the recall Friday. An incorrect reading could potentially lead to dangerous medication errors for patients.
The strips covered by the recall are marketed under the brand names Nova Max Blood Glucose Test Strips and Nova Max Plus Glucose Meter Kits. The recall affects certain lots of the strips distributed in the U.S., Canada, Chile, Peru, Argentina, the Dominican Republic, Jamaica and a half-dozen other countries. Nova Diabetes Care sells them through retail stores and websites.
The FDA said Wednesday that the strips are contaminated with a chemical used in the manufacturing process, which interferes with readings. FDA regulators are working with the company to investigate the problem and make sure it is corrected.
Patients can visit a company website to check if their glucose test strips are affected by the recall: www.novacares.com/news/nova-max-recall.php . They can also call a company hotline at 1-800-681-7390. Customers can return the strips and receive replacements at no charge.
Doctors and patients should pay attention for signs and symptoms of high or low blood sugar levels, including excessive thirst, nausea, weakness, headaches and trembling.
"It is important that patients using these test strips discontinue their use immediately," said Alberto Gutierrez, director of FDA's office of in vitro diagnostics. "A false reading could result in patient harm and delay critical care."