Nova Max Glucose Test Strips and Nova Max Plus Glucose Meter kits were voluntarily recalled due to inaccurate readings.
The recall included approximately 62 million strips.
The strips are reportedly producing results that are falsely elevated. False readings can result in improper care leading to extreme reactions. The strips were sold in retail locations and delivered directly to consumers via online purchases.
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.
You can find specific information about affected lot numbers by calling Nova Diabetes Care at 1-800-681-7390. Or you can visit their website at: www.novacares.com/news/nova-max-recall.php