Nova Diabetes Care is recalling of 21 lots of the Nova Max Glucose Test Strips distributed both in the USA and outside the continental USA. Nova Max Plus glucose meter kits that include test strips from the recalled lots are also included in the recall.
The company has recently determined that some of the blood glucose test strips contained within the indicated Nova Max Glucose Test Strip lots and Nova Max Plus glucose meter kits may report a false, abnormally high blood glucose result. Those who use, recommend clinically, or sell Nova Max Glucose Test Strips for blood glucose testing should immediately discontinue using or distributing glucose test strips from the following lots:
Nova Max Test Strip Recalled Lots
| Test Strip Lot Number |
|---|
| 1020211346 |
| 1020411347 |
| 1020611348 |
| 1020811350 |
| 1020211355 |
| 1020212032 |
| 1020512087 |
| 1020212100 |
| 1020212101 |
| 1020212153 |
| 1020712206 |
| 1020212207 |
| 1020412255 |
| 1020212291 |
| 1020912292 |
| 1020412341 |
| 1020213043 |
| 1020213074 |
| 1020213109 |
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.
Customers can check to confirm if they have blood glucose test strips from the affected lots from the above list, by visiting www.novacares.com/news/nova-max-recall.php or by contacting Nova Diabetes Care customer service at 1-800-681-7390.
Customers may continue to test blood glucose using any other Nova Max Glucose Test Strip lot not indicated as part of this recall while waiting for their replacement to arrive.
No other product or lot number from Nova Diabetes Care is affected by this recall. Customers may continue to test blood glucose using any other Nova Max Glucose Test Strip lot not indicated as part of this recall while waiting for their replacement to arrive.
Customers can contact Nova Diabetes Care customer service at 1-800-681-7390 to replace their affected test strip lot or meter kit at no charge.
In the event that a customer must use affected test strips from the indicated lots above while waiting for replacement product to arrive, Nova Diabetes Care recommends customers take the following precautions:
- As stated in the Blood Glucose Monitor Owners Guide and Nova Max Glucose Test Strip Product Insert, customers should perform a quality control solution test to confirm that the vial of Nova Max Glucose Test Strips is working correctly. Customers should not use a test strip vial if control solution results are not within the expected range.
- Customers should verify all elevated blood glucose test results that are not consistent with their 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).
- Customers should contact their health care provider immediately if their reported blood glucose result(s) are not consistent with their diabetes history, how they feel, or if they think their results are not accurate (higher than expected).
- Customers should never ignore symptoms or make significant changes to their diabetes management program without speaking to their health care professional.
Customers can contact Nova Diabetes Care customer service at 1-800-681-7390 to replace their affected test strip lot or meter kit at no charge.