DEVICE RECALLS - TRUEbalance Blood Glucose Meters and TRUEtrack Blood Glucose Meters
On January 2, 2014, Nipro Diagnostics, Inc. issued a voluntary recall of TRUEbalanceTM Blood Glucose Meters and TRUEtrack® Blood Glucose Meters which are used for testing blood glucose levels in Diabetes patients.
The recalled TRUEbalanceTM Blood Glucose Meters and TRUEtrack® Blood Glucose Meters are displaying glucose results incorrectly with blood glucose results reading in mmoi/L rather than mg/dl as they should. Patients may not notice the incorrect unit of measure and may have lower blood glucose levels than perceived. Incorrect blood glucose results may delay medical attention and proper treatment for hypoglycemia and potentially lead to serious injury.
Consumers should check if their TRUEbalanceTM Blood Glucose Meters and TRUEtrack® Blood Glucose Meters have been affected by this recall by visiting www.NiproDiagnostics.com/product-notice or by calling Stericycle toll-free at 1-866-236-4518.
Nipro Diagnostics is offering to replace all TRUEbalanceTM Blood Glucose Meters and TRUEtrack® Blood Glucose Meters at no charge with an expedited return. Consumers with affected TRUEbalanceTM and TRUEtrack® Meters can contact Stericycle toll-free at 1-866-236-4518.
If you have any questions about this recall please contact your local retail pharmacist or speak to your doctor.
No adverse health reactions have been associated with this recall.
Adverse events that may be related to the use of these products may also be reported to the United States Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting Program either online, by regular mail, or by fax:
Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail the form to: MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787