Nova Diabetes Care recalls 62 mn faulty glucose test strips
02 Aug 2013
Nova Diabetes Care, a US-based blood testing devices maker, is recalling up to 62 million glucose test strips as they may show incorrect blood sugar level readings.
The strips covered by the recall are marketed under the brand names Nova Max Blood Glucose Test Strips and Nova Max Plus Glucose Meter kits.
The recall affects 21 lots of strips sold in the US, Canada, Chile, Peru, Argentina, the Dominican Republic, Jamaica and a six other countries.
Nova Diabetes Care sells the strips through retail stores and websites.
The US Food and Drug Administration (FDA) said that patients should immediately discontinue use of the strips since an error could prompt patients to take an excessive dose of insulin, which could lead to hypoglycemia and other serious health risks.
The FDA said that the strips are contaminated with a chemical used in the manufacturing process, which interferes with readings.
''It is important that patients using these test strips discontinue their use immediately,'' said Alberto Gutierrez, director at FDA. ''A false reading could result in patient harm and delay critical care.''
Upon identifying the issue, Nova Diabetes Care said that it promptly notified all registered users, health care professionals, pharmacies, and distributors where the Test Strip and glucose meter kit are sold.
The Massachusetts-based company also said that it has taken the necessary corrective actions to prevent this situation from recurring.
