Nipro Diagnostics, Inc. today announced it is initiating a voluntary recall and replacement of a limited number of TRUEbalanceTM and TRUEtrack® Blood Glucose Meters distributed both in and outside the United States.
The company has determined that certain isolated TRUEbalance and TRUEtrack Blood Glucose Meters distributed in the United States have an incorrect factory-set unit of measure that displays the glucose result in mmol/L rather than mg/dL. If a consumer were not to notice the incorrect unit of measure, it is possible that the meter result could be read as a lower than expected blood glucose result.
The meters in question were distributed in the United States from September 2008 to May 2013.
Consumers who have a TRUEbalance or TRUEtrack meter should:
• Check to confirm if they have an affected TRUEbalance or TRUEtrack meter by obtaining the serial number from the serial number label on the back of the meter and visiting www.NiproDiagnostics.com/product-notice or by calling Stericycle toll-free at 1-866-236-4518.
• If the consumer has an affected TRUEbalance or TRUEtrack meter, please call Stericycle to verify serial number, and to expedite return and replacement of these affected TRUEbalance and TRUEtrack meters at no charge.
Consumers may continue to test blood glucose using any other Nipro Diagnostics blood glucose meter not included in this recall while waiting for their replacement meter to arrive. Only use test strips that are intended for use with their blood glucose meter.
There have been no reports of patient injuries or adverse events related to this recall.
The company is sending notifications to pharmacies, durable medical equipment providers, mail order companies, and distributors where the TRUEbalance and TRUEtrack meters are recommended or sold in the United States.
Nipro Diagnostics has notified the U.S. Food and Drug Administration of this voluntary product recall.