Health Canada, the Federal department responsible for helping Canadians to maintain and improve their health, has informed Canadians of a voluntary recall of certain lots of Nova Max Blood Glucose Test Strips that were contaminated during the manufacturing process. This recall also affected the unused Nova Max Plus Glucose Meter Kits, which contain test strips from the recalled lots.
The test strips under recall may report a false, abnormally high blood glucose result. Under certain conditions, such a false result could lead users with diabetes to an insulin dosing error, requiring the user to seek immediate medical attention.
The test strips are sold in retail stores/pharmacies, online directly to consumers, and may be used in health care facilities.
Consumers using strips from the recalled lots should immediately stop using them and take the necessary steps to continue to monitor their blood sugar. The Canadian distributor, Nova Biomedical Canada Ltd., is providing additional guidance for customers, and Canadians can also consult their healthcare professional if they have concerns about glucose test results obtained using the strips.
Patients should not make significant changes to their diabetes management programme without speaking to their healthcare professional.
Healthcare professionals and pharmacists with unused kits involved in the recall should remove them from circulation immediately.
Insulin dosing errors can lead to high blood sugar (hyperglycemia) or low blood sugar (hypoglycemia). Symptoms of high blood sugar include excessive thirst, excessive urination, blurred vision, weakness, nausea, vomiting, and abdominal pain. Symptoms of low blood sugar include trembling, excessive sweating, weakness, hunger, confusion, and headache. Some individuals may experience no symptoms before experiencing unconsciousness or seizures.
Consumer complaints involving medical devices can be reported to the Health Products and Food Branch Inspectorate by calling the toll-free hotline at 1-800-267-9675.