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Nipro Diagnostics, Inc. Initiates Voluntary Recall of Certain TRUEbalance and TRUEtrack Blood Glucose Meters

  Nipro Diagnostics, Inc. Initiates Voluntary Recall of Certain TRUEbalance
  and TRUEtrack Blood Glucose Meters

Business Wire

FORT LAUDERDALE, Fla. -- January 2, 2014

Nipro Diagnostics, Inc. today announced it is initiating a voluntary recall
and replacement of a limited number of TRUEbalance^TM 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 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.

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.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.

We have 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, Florida, Nipro
Diagnostics, Inc. is a leading developer, manufacturer and marketer of
diabetes monitoring and management products. The company offers a portfolio of
high-quality blood glucose monitoring systems and diabetes management products
available around the world. Nipro Diagnostics is the exclusive supplier of
blood glucose monitoring systems, co-branded under the TRUE name, to the
world’s leading pharmacies, distributors and mail service providers. For more
information, please visit: www.niprodiagnostics.com

Contact:

Nipro Diagnostics, Inc.
Lisa Nardi, 800-342-7226, Ext. 2183
Vice President, Marketing
www.NiproDiagnostics.com
 
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