News Releases

January 8, 2014

Nipro Diagnostics, Inc. Recalls TRUEbalance and TRUEtrack Blood Glucose Meters

The Missouri Department of Health and Senior Services received information regarding a recall 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 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:

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 full recall can be found at www.fda.gov/Safety/Recalls/ucm380679.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery.

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