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FDA announces a voluntary recall of Nova Max Blood Glucose Test Strips
The U.S. Food and Drug Administration is working with Nova Diabetes Care to recall 21 lots of glucose test strips marketed under the brand names Nova Max Blood Glucose Test Strips and Nova Max Plus Glucose Meter Kits.
The test strips under recall may report a false, abnormally high blood glucose result. Under certain conditions, a false, abnormally high blood glucose level could result in an insulin dosing error, requiring the user to seek immediate medical attention.
The test strips, which were manufactured from December 2011 to April 2013, are sold in retail stores and online directly to consumers, and are used in health care facilities. The test strips became contaminated with a chemical used during the manufacturing process. The FDA is working with Nova to investigate the problem and prevent it from recurring.
“It is important that patients using these test strips discontinue their use immediately,” said Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health in FDA’s Center for Devices and Radiological Health. “A false reading could result in patient harm and delay critical care.”