Nova Max Glucose Test Strip Recall Issued Due to False Results

A recall has been issued for 21 lots of Nova Max glucose test strips, after the manufacturer recognized that kits may provide a false and abnormally high reading, potentially causing an insulin dosing error that could lead to severe health consequences.  

The Nova Max Plus glucose test strip recall was announced by the FDA on July 26, due to problems where the test strips may show elevated and inaccurate blood glucose levels. Users are at an increased risk if the results show high blood glucose levels because they may not be receiving the proper dosage required to treat their diabetes.

The recall includes the following 21 lots of the Nova Max Plus glucose kits with test strips; 1020211346, 1020411347, 1020611348, 1020811350, 1020211355, 1020212032, 1020512087, 1020212100, 1020212101, 1020212153, 1020712206, 1020212207, 1020412255, 1020212291, 1020912292, 1020412341, 1020213043, 1020213074, and 1020213109.

The FDA recommends that consumers with affected test strips stop using the products immediately and contact their health care provider for an alternative testing regimen. In the event that a user must use the affected test strips until an alternative solution is selected, the FDA indicates that users should discontinue the use if the control solutions are not within their expected range, confirm a high test strip readings with a different vial if the results are not consistent with their medical history, and to never ignore symptoms or make significant changes to their diabetes control strategy without consulting with their healthcare provider first.

Symptoms of high blood sugar include excessive urination, excessive thirst, nausea, vomiting, weakness, and abdominal pain. Symptoms of low blood sugar usually include consistent headaches, sweating, trembling, and in some cases individuals may experience unconsciousness or seizures.

Nova Max announced it has notified all medical health providers and is working with the FDA to take all of the precautionary steps to prevent similar problems from occurring. Users with abnormal test readings are encouraged to contact their healthcare provider.

Customers not sure if their test strips are affected or customers with known affected test strips may contact Nova Max at 1-800-681-7390 to receive a free replacement test kit. Consumers with questions can also visit the company’s website at www.novacares.com/news.nova-max-recall.php.