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eMedAlert
Emed Alert for TRUEbalance & TRUEtrack BLOOD GLUCOSE METERS
 

URGENT: MEDICAL DEVICE VOLUNTARY RECALL

CERTAIN TRUEbalance™ & truetrack® BLOOD GLUCOSE METERS

 

December 31, 2013

 

Dear Valued Customer:

 

The purpose of this letter is to inform you that Nipro Diagnostics, Inc. has announced a voluntary product recall of a limited number of TRUEbalance™ & truetrack® blood glucose meters.  The company has determined that certain isolated TRUEbalance and TRUEtrack Blood Glucose Meters distributed both inside and outside the United States have an incorrect factory-set unit of measure.  In the United States, the meter 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.  We have not received any reports of patient injuries or adverse events related to this recall.  

 

Replacement meters are available at no charge by following the instructions provided below:

 

- Determine whether you 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.  Stericycle can verify affected meters by serial number and will expedite return and replacement of these TRUEbalance and TRUEtrack meters at no charge to you.  Discontinue use of any affected meter.  You may continue to test blood glucose using any other Nipro Diagnostics blood glucose meter not included in this recall while waiting for your replacement meter to arrive.  Only use test strips that are intended for use with your meter. 

- This recall is being made with the knowledge of the Food and Drug Administration

- Patient safety is a top priority at Nipro Diagnostics and we apologize for any inconvenience this recall may cause you. 

Sincerely,

Nipro Diagnostics

 

 

Appendix: Meter Lot Numbers

Product Name

TRUEbalance

TRUEtrack

Finished Goods

KK0468

KJ0731

Lot Numbers

KL01079

KK0964

 

KM0337TI

KL01213

 

KN1834TI

KL01233-3TI

 

KN1973TI

KL0267-10

 

KN2074TI

KL0381-14

 

KN2089TI

KL0637-2TI

 

KN2090TI

KL0716TI

 

KN2102TI

KL0860TI

 

KP0047TI

KP0074TI

 

KP0076TI

 

 

KP0128TI

 

 

KP0925TI