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January 10 11:58 AM

Voluntary recall of certain TRUEbalance and TRUEtrack Blood Glucose Meters by Nipro Diagnostics Inc.


FORT LAUDERDALE, Fla. — Nipro Diagnostics Inc. has announced it is initiating 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 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 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.

There are 501 affected TRUEbalance meters and 105 affected TRUEtrack meters that 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.Nipro Diagnostics.com/productnotice or by calling Stericycle tollfree 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.

The FDA has not received any 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.

Patient safety is a top priority at Nipro Diagnostics. The company has notified the U.S. Food and Drug Administration (FDA) of this voluntary product recall and is working with affiliates in other countries to notify regulatory authorities where the affected products were sold to quickly resolve this matter.

About Nipro Diagnostics Inc.: Based in Fort Lauderdale, Fla., Nipro Diagnostics Inc. is a leading developer, manufacturer and marketer of diabetes monitoring and management products. The company offers a portfolio of highquality blood glucose monitoring systems and diabetes management products available around the world. Nipro Diagnostics is the exclusive supplier of blood glucose monitoring systems, cobranded under the TRUE name, to the world's leading pharmacies, distributors and mail service providers. For more information, please visit: www.niprodiagnostics.com.

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