Nova Diabetes Care is recalling up to 62 million glucose test strips that show an incorrect high sugar level reading, the U.S. Food and Drug Administration said Wednesday.
The voluntary recall was announced by the company Friday for products sold as under the brand names of Max Blood Glucose Test Strips and Nova Max Plus Glucose Meter Kits.
The strips were sold in the U.S. and in 13 countries and Puerto Rico, the FDA said in statement.
The federal agency warned that the inaccurate reading could cause users to administer an incorrect dosage error, leading some to seek immediately medical attention.
“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.
Customers can check to find out whether they have blood glucose test strips from the affected lots by visiting the company's site here or by contacting Nova Diabetes Care customer service at (800) 681-7390.
The FDA said the strips were contaminated with a chemical used in the manufacturing process, which interferes with readings.
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