Recall of 62 Million Diabetes Test Strips
The Food and Drug Administration is warning patients with diabetes about the recall of 62 million glucose test strips used to measure blood sugar levels.
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.
“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.
The recalled test strips 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 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.
Click Links for more information:
Nova Max® website to see glucose test strips affected by the recall