About 62 million glucose test strips used by diabetics are being recalled because they provide a false reading of sugar levels in the blood, federal health officials say.
Sold under the brand names Nova Max Blood Glucose Test Strips and Nova Max Plus Glucose Meter Kits, the strips may report a false, abnormally high blood glucose result.
"People with diabetes make self-management decisions based on blood glucose readings, so accuracy of the results is critical," said Virginia Peragallo-Dittko, executive director of the Diabetes and Obesity Institute at Winthrop-University Hospital in Mineola.
When diabetics receive a high reading, they might under circumstances involving defective test strips adjust a dosage of insulin upward, leading to extreme hypoglycemia -- low blood sugar, Peragallo-Dittko said.
Symptoms of low blood glucose include shaking, sweating and confusion. People can pass out or have seizures or possibly die if low blood glucose is not treated immediately.
"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 at the U.S. Food and Drug Administration.
"A false reading could result in patient harm and delay critical care," Gutierrez said.
The test strips, which were manufactured from December 2011 to April 2013, are sold in retail stores and online directly to consumers, and are also used in health care facilities.
The strips became contaminated with a chemical used during the manufacturing process, according to the FDA. The agency is working with Nova to investigate the problem and prevent it from recurring.
The test strips were distributed throughout the United States, Canada, Chile, Peru, Argentina, the Dominican Republic, Jamaica, Puerto Rico, United Kingdom, Germany, Belgium, Finland, Congo and Saudi Arabia.