Medical device maker, Nipro Diagnostics, has issued a recall of its TRUEbalance and TRUEtrack Blood Glucose Meters over an incorrect factory-set measure, according to the U.S. Food and Drug Administration (FDA).
Nipro Diagnostics indicated that it replaced some TRUEbalance and TRUEtrack blood glucose meters that were distributed within the United States and globally.
Nipro Diagnostics found that some isolated TRUEbalance and TRUEtrack Blood Glucose Meters have an incorrect factory set unit of measure that displays the glucose result in mmoi/L. This unit of measure should display in mg/dl.
Should a patient not notice that the incorrect unit of measure was being used, there exists the potential that the meter reading could be read as a lower-than-expected blood glucose result.
In all, there are 501 TRUEbalance meters and 105 TRUEtrack meters that are impacted and which were distributed in the United States. The recalled Nipro devices were distributed from September 2008 to May 2013.
Nipro indicated that it is advising pharmacies, durable medical equipment providers, mail order companies, and distributors as to where TRUEbalance and TRUEtrack meters have been recommended or sold in the United States.
Consumers in possession of either a TRUEbalance or TRUEtrack meter should:
- Confirm possession of the recalled TRUEbalance or TRUEtrack meter by obtaining the serial number from the serial number label on the back of the meter. This number is to be checked against information at www.NiproDiagnostics.com/product-notice and may also be confirmed by calling Stericycle, toll-free, at 1.866.236.4518.
- If a consumer is in possession of an affected TRUEbalance or TRUEtrack meter, please call Stericycle to verify the serial number and expedite return and replacement of the affected TRUEbalance and TRUEtrack meters. This is being done at no charge to customers.
The recall notice indicates that consumers may continue to conduct blood glucose testing using any other Nipro Diagnostics blood glucose meter that is not discussed in this recall while waiting for the replacement meter to arrive. Only those test strips intended for use with the blood glucose meter should be used.
According to Nipro, no reports of patient injuries or adverse events related to this recall have been received, to date.