Nova Diabetes Care is recalling 62 million glucose test strip after they discovered some of the strips can show abnormally high blood sugar readings.
The recall includes 21 lots of glucose test strips marketed under the brand names Nova Max Blood Glucose Test Strips and Nova Max Plus Glucose Meter Kits.
Nova Diabetes Care announced a recall on July 26, 2013.
The recall pertains to certain lots of these test strips distributed in the United States, Canada, Chile, Peru, Argentina, Dominican Republic, Jamaica, Puerto Rico, United Kingdom, Germany, Belgium, Finland, Congo, and Saudi Arabia. As many as 62 million strips may be affected by the recall. Other Nova Diabetes Care products are not affected by the recall.
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.”
The FDA has provided recommendations for people with diabetes and health care professionals below that explain how to determine whether a particular lot is affected, how to order free replacement strips and precautions to take if consumers must use the recalled strips.