Urgent Medical Device Voluntary Recall False Abnormally High Blood Glucose Results
Customer Advisory Notice: 01-13NM, USA
Dear Valued Customers:
If you use, recommend or sell the Nova Max® Blood Glucose Test Strips or Nova Max® Plus™ Blood Glucose Monitoring System this is to notify you that Nova Biomedical Diabetes Care (Nova Diabetes Care) is voluntarily recalling and replacing the indicated Nova Max Glucose Test Strip lot numbers and unused Nova Max Plus Glucose Meter Kits listed in the attached Appendix.
We have recently determined that some of the blood glucose test strips contained within the Nova Max Glucose Test Strip lots listed in the attached Appendix may report a false, abnormally high blood glucose result. A false, abnormally high blood glucose result could, under certain conditions, result in an insulin dosing error that could lead to a serious health risk requiring immediate medical attention. Nova Diabetes Care has decided to replace the Nova Max Glucose Test Strips and Nova Max Plus Glucose Meter Kits listed in the attached Appendix at No Charge.
There are no other Nova Diabetes Care products or lot numbers impacted by this recall.
People with Diabetes:
Immediately discontinue use of Nova Max Glucose Test Strips from the indicated lot numbers. In Order To Receive Replacement Product At No Charge, Please Follow The Steps Below:
Please call Nova Diabetes Care Customer Service at 1-800-681-7390 to verify the Lot # for your Nova Max Glucose Test Strips and Nova Max Plus Glucose Meter Kit and confirm your mailing address so that we may ship you replacement product. Please print and keep this notice with your Owner’s Booklet. You may continue to test your blood glucose with your current blood glucose meter(s) using any other Nova Max Glucose Test Strip lot not indicated as part of this recall while you wait for your replacement product to arrive.
While you wait for your replacement product to arrive, do not stop testing your blood glucose. In the event that you must use affected test strips from the lots indicated in the attached Appendix, Nova Diabetes Care recommends that you take the following precautions:
- As stated in your Blood Glucose Monitor Owners Guide and Nova Max Glucose Test Strip Product Insert, perform a quality control solution test to confirm that your vial of Nova Max Glucose Test Strips is working correctly. Do not use a test strip vial if control solution results are not within the expected range.
- Verify all elevated blood glucose test results that are not consistent with your diabetes history by repeating the test using a new blood glucose test strip from a different vial (if available) or the same vial (if a new vial is unavailable).
- Contact your health care provider immediately if your reported blood glucose result(s) are not consistent with your diabetes history, how you feel, or if you think your results are not accurate (higher than expected).
- Never ignore symptoms or make significant changes to your diabetes management program without speaking to your health care professional.
People with Diabetes should be aware of symptoms of high blood sugar (hyperglycemia) and low blood sugar (hypoglycemia). Contact your healthcare professional for advice on how to treat the symptoms noted below.
- 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. It is important to treat low blood sugars promptly to avoid loss of consciousness or seizure.
Healthcare Professionals:
Immediately discontinue distributing the indicated Catalog Numbers/Lot Numbers in the attached Appendix to patients and collect all samples that are in your possession. Call 1-800-681-7390 so that we may ship you replacement product and expedite the return of the recalled product. If you have any additional questions, please contact your local Nova Diabetes Care sales representative or Nova Diabetes Care Customer Service at 1-800-681-7390. While Nova Diabetes Care will be notifying known patients directly, we also request your assistance in sharing this information with your patients who use the Nova Max Glucose Test Strips and Nova Max Plus Glucose Meter.
Patients may continue to test their blood glucose using any other Nova Max Glucose Test Strip lot not indicated as part of this recall while they wait for their replacement product to arrive. However, patients should discontinue testing blood glucose using Nova Max Glucose Test Strips from the lots listed in the attached Appendix. Please refer any patients with recalled product or questions to Nova Diabetes Care Customer Service at 1-800-681-7390. In the event that your patients must use affected test strips from the lots indicated in the Appendix, Nova Diabetes Care recommends that they follow the instructions indicated in the section entitled “People with Diabetes”.
Pharmacists:
Immediately identify and return all Nova Max Glucose Test Strips and Nova Max Plus Meter Kits from the indicated Catalog Numbers/Lot Numbers in the attached Appendix that you have in inventory for a credit following your normal return procedures. While Nova Diabetes Care will be notifying known patients directly, we also request your assistance in sharing this information with your patients who use the Nova Max Glucose Test Strips and Nova Max Plus Glucose Meter.
Patients may continue to test their blood glucose using any other Nova Max Glucose Test Strip lot not indicated as part of this recall while they wait for their replacement product to arrive. However, patients should discontinue testing blood glucose using Nova Max Glucose Test Strips from the lots listed in the Appendix. Please refer any patients with recalled product or questions to Nova Diabetes Care Customer Service at 1-800-681-7390. Please call Nova Diabetes Care Customer Service at 1-800-681-7390 if you have questions about this action. In the event that your patients must use affected test strips from the lots listed in the Appendix, Nova Diabetes Care recommends that they follow the instructions indicated in the section entitled “People with Diabetes”.
Distributors:
Immediately identify and hold all Nova Max Test Strips and Nova Max Plus Meter Kits from the indicated Catalog Numbers/Lot Numbers you have in inventory. Communicate this replacement program to your customers that purchased the indicated product from you. Request that they return only the indicated Catalog Numbers/Lot Numbers per your normal return procedures. Once you have received all product to be returned, call Nova Diabetes Care at 1-800-681-7390 for a returned goods authorization (RGA) and product return instructions.
Nova Diabetes Care remains committed to providing you with the highest quality products and services. We apologize for the inconvenience this issue will cause. Thank you for your continued support of Nova Diabetes Care products. Additional information regarding this recall can be found at www.novacares.com/news/nova-max-recall.php.
Sincerely,
Nova Diabetes Care
Nova Biomedical Corporation
Appendix A: Recalled Lot Numbers / Catalog Numbers
Nova Max Test Strip Recalled Lots
Nova Max Plus Meter Kit Recalled Lots
