Nova Diabetes Care has issued a voluntary product recall for 62 million glucose test strips which can show an incorrect high sugar level reading, according to an announcement from the Food and Drug Administration on Wednesday, July 31st.
On Friday, July 26th, the company announced the voluntary product recall for products sold under brand names Max Blood Glucose Test Strips, and Nova Max Plus Glucose Meter Kits. The strips were sold in the US and Puerto Rico, as well as 13 other countries, according to the manufacturer.
Nova Diabetes Care also announced that none of their other glucose testing products are affected by the product recall, and consumers can continue to use other kits. However, the manufacturer strongly recommends that consumers cease using affected lots.
“It is important that patients using these test strips discontinue their use immediately,” said Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health in FDA’s Center for Devices and Radiological Health. “A false reading could result in patient harm and delay critical care.
However, if a customer must continue to use the affected lots under recall, Nova Diabetes Care has issued some guidelines for use until the product can be replaced:
1. 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.
2. 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).
3. 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).
4. Customers should never ignore symptoms or make significant changes to their diabetes management program without speaking to their health care professional.
The FDA said the strips are under product recall because they became contaminated with a chemical used in the manufacturing process, which can interfere with readings.
Customers can check to confirm if they have blood glucose test strips from the affected lots by visiting www.novacares.com/news/nova-
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