FDA issues recall notice on Nova strips
Providers should monitor residents with diabetes to see if they are using recalled blood glucose test trips, the U.S. Food and Drug Administration has advised.
The recall affects as many as 62 million strips, which are marketed as Nova Max Blood Glucose Test Strips or Nova Max Plus Glucose Meter Kits. The voluntary recall was announced July 26.
The strips, from 21 lots, are being recalled because they might report a false, abnormally high blood glucose result. That can lead to an insulin dosing error.
The strips were distributed in the United States, Canada, Chile, Peru, Argentina, the Dominican Republic, Jamaica, Puerto Rico, the United Kingdom, Germany, Belgium, Finland, Congo and Saudi Arabia.They were manufactured from December 2011 to April 2013, are used in healthcare facilities and are available in retail stores. The strips became contaminated during manufacturing, the FDA said.
“Upon identifying the issue, Nova Diabetes Care promptly notified all registered users, healthcare professionals, pharmacies and distributors where the Nova Max Glucose Test Strip and Nova Max Plus glucose meter kit are recommended or sold,” the company said in a statement. “We apologize for any inconvenience this issue may cause.”
Consumers can visit www.novacares.com/news/nova-max-recall.php to see if they have recalled strips.
Those with diabetes should continue to test their blood glucose, even if affected test strips are the only ones available. To reduce the chance of a false reading, the FDA recommends performing a quality control solution test, details of which can be found in the owner's manual. Providers can call Nova at (800) 681-7390 for replacements.
Other glucose test strips also have been recalled recently. In 2010, the FDA and Abbott Diabetes Care recalled 359 different lots of glucose test strips marketed under the brand names of Precision Xceed Pro, Precision Xtra, Medisense Optium, Optium, OptiumEZ and ReliOn Ultima.