By: Russell Maas | Published: January 9th, 2014
A recall has been issued for more than 600 Nipro TRUEbalance and TRUEtrack blood glucose meters, after the manufacturer recognized the machines may display measurements in an incorrect factory set-unit of measure, potentially causing diabetics to suffer to suffer serious health problems as a result of delayed treatment or taking the wrong course of action.
The TRUEbalance and TRUEtrack glucose meter recall was announced by the U.S. Food and Drug Administration on January 2, due to a risk that the monitor may display results in mmol/L (millimoles/liter), rather than mg/dl (milligrams/deciliter).
If the user is not aware of the change in measurement, it may lead them to believe their glucose levels are higher or lower than normal readings, causing them to take inappropriate courses of action. The machines may also show inadequate readings, which would lead users to believe their glucose levels are sufficient, potentially causing a delay in medical treatment that could lead to insulin under dosage.
The recall includes an estimated 501 Nipro Diagnostics TRUEbalance units and 105 TRUEtrack blood glucose meter units distributed from September 2008 to May 2013.
Customers may verify if their meters are included in the recall by locating a white label on the back of the machine that will display a 7-digit serial number beginning with the letter “B” for TRUEbalance meters and the letter “E” for TRUEtrack meters. Customers may verify if their machine is part of the recall by visiting http://www.niprodiagnostics.com/product-notice.aspx and plugging in the appropriate serial number beginning with “B” or “E”.
Customers with recalled glucose meters should contact Stericycle immediately at 1-866-236-4518 to expedite return and replacement of the machine free of charge from Nipro Diagnostics. Customers should find an alternative method for testing glucose levels until their replacement machine is provided.
The recall comes just days after the FDA announced a Class I medical device recall of Abbott FreeStyle and FreeStyle Lite Blood Glucose Test Strips, warning that the strips may give erroneously low blood glucose results, which could lead to a misdiagnosis and a failure to properly treat high blood sugar levels, too much carbohydrate intake, or an insulin under dose.
This recall also comes less than a year after Abbott announced another recall of 50,000 FreeStyle Insulix Blood Glucose Meters due to the device’s malfunctioning and displaying glucose levels up to 1,024 mg per deciliter lower than the actual level, also posing a risk of delayed treatment.