|[January 02, 2014]
Nipro Diagnostics, Inc. Initiates Voluntary Recall of Certain TRUEbalance and TRUEtrack Blood Glucose Meters
FORT LAUDERDALE, Fla. --(Business Wire)--
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 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
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
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
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
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