Truebalance and Truetrack Blood Glucose Meters by Nipro Diagnostics: Recall - Incorrect Factory-set Measure

[Posted 01/08/2014]

AUDIENCE: Consumer, Pharmacy

ISSUE: Nipro Diagnostics initiated a voluntary recall and replacement of a limited number of TRUEbalance and TRUEtrack Blood Glucose Meters distributed both in the United States and outside the United States.

The company determined that certain isolated TRUEbalance and TRUEtrack Blood Glucose Meters have an incorrect factory-set unit of measure that displays the glucose result in mmoi/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.

BACKGROUND: There are 501 affected TRUEbalance meters and 105 affected TRUEtrack meters that were distributed in the United States from September 2008 to May 2013. 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.

RECOMMENDATION: 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.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[01/02/2014 - Press Release - Nipro Diagnostics, Inc]
[01/02/2014 - Product Photos - Nipro Diagnostics, Inc]