FDA Deems Nova Glucose Test Strip Recall a Class I

Nova Medical just issued a recall over its Nova Max test strips and glucose meter kits. According to the U.S. Food and Drug Administration (FDA), the recall has been designated a Class I.

Recalls are actions taken by a firm to remove a product from the market. A Class I recall is a situation in which there is a reasonable probability that the use of or exposure to a violative, or recalled product, will cause serious adverse health consequences or death.

The products might display a false, abnormally high blood glucose results, according to MassDevice.com, which could lead to an inappropriate insulin dosing by the patient. The recalled Nova Max strips and other products are sold directly to patients at larger stores such as CVS, Rite Aid, and Walmart, as well as through mail-order services for diabetics.

Last month, Nova sent a letter to impacted customers that warned them to stop using the recalled products immediately, according to MassDevice.com. The recall involves 19 lots of glucose strips and 60 lots of monitoring kits. Nova said it would ship new replacement kits to its customers and advised customers to manage blood glucose with other products until the replacements arrive.

“Under certain conditions a false, abnormally high blood glucose level could result in an insulin dosing error that may lead to low blood glucose (hypoglycemia) requiring the user to seek immediate medical attention,” the FDA stated in its recall announcement.

The FDA also indicated that the recalled products were distributed in the United States as well as outside of the continental U.S.

Nova’s page describing the recall may be accessed at:  www.novacares.com/news/nova-max-recall.php. Nova Diabetes Care Customer Service may be reached, toll-free, at 1.800.681.7390.

The FDA warns that people diagnosed with diabetes should be aware of the symptoms of hyperglycemia (high blood sugar) and hypoglycemia (low blood sugar).