Around 62 million faulty glucose test strips thought to give a false, abnormally high blood glucose result are being recalled by the US Food and Drug Administration and Nova Diabetes Care.
Twenty-one lots of the Nova Max Blood Glucose Test Strips and Nova Max Plus Glucose Meter Kits are being recalled.
The test strips became contaminated with a chemical used during the manufacturing process.
FDA’s Center for Devices and Radiological Health’s Office of In Vitro Diagnostics and Radiological Health director Alberto Gutierrez said:"It is important that patients using these test strips discontinue their use immediately. A false reading could result in patient harm and delay critical care."
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 recall affects certain lots of these test strips distributed in the US, as well as Argentina, Belgium, Canada, Chile, Congo, Dominican Republic, Finland, Germany, Jamaica, Puerto Rico, Peru, Saudi Arabia and the UK.
The test strips were manufactured in December 2011 to April 2013 and are sold online and in retail stores, as well as being used in health care facilities.