Wrong readouts prompt blood glucose meter recall
Wrong readouts on blood glucose monitors prompt recall
Nipro Diagnostics is voluntarily recalling certain TRUEbalance and TRUEtrack blood glucose meters due to an incorrect factory setting that's causing the meters to display glucose results in mmol/L rather than mg/dl.
"If a consumer were not to notice the incorrect uit of measure, it is possible that the meter result could be read as a lower than expected blood glucose result," the FDA said in a press release.
The recall affects 501 TRUEbalance meters and 105 TRUEtrack meters distributed in the United States from Sept. 2008 to May 2013. Patients can check if their meter is affected by checking the serial number on the back of the device against the manufacturer's list or by calling Stericycle toll-free at 1-866-236-4518. Nipro will replace all affected meters free of charge.
Thus far, there have been no reports of injuries or adverse events related to the recall. Clinicians can report any adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.