The U.S. Food and Drug Administration (FDA), working with Nova Diabetes Care, announced the recall of 21 lots of blood glucose test strips sold 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. According to the FDA, the test strips under recall may report a false, abnormally high blood glucose result. A false, abnormally high blood glucose level could result in an insulin dosing error, requiring the user to seek immediate medical attention.
According to the FDA news release, the recalled lots of these test strips were 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. The FDA reports that the test strips became contaminated with a chemical used during the manufacturing process. The agency is working with Nova to investigate the problem and prevent a recurrence. The recalled test strips were manufactured between December 2011 and April 2013. They are sold in retail stores and online to consumers and are used in health care facilities.
Anyone with strips from the affected lots should stop using them immediately. Consumers can confirm whether they have the recalled strips by visiting www.novacares.com/news/nova-max-recall.php or by contacting Nova Diabetes Care customer service at 1-800-681-7390. The company will provide free replacement strips and advise consumers about proper precautions if they must continue using the recalled strips.
The FDA urges patients are urged to pay special attention to signs and symptoms of high blood sugar (hyperglycemia) and low blood sugar (hypoglycemia) and to contact a health care provider immediately if their blood glucose result(s) are not consistent with their diabetes history, with how they feel, or if they think the results are not accurate (i.e., are higher than expected).