FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Trividia Health, Inc., formerly Nipro Diagnostics, today announced it is initiating a voluntary recall of a limited number of TRUEread®, TRUEbalance®, TRUEtrack® & TRUEtest® blood glucose test strip lots distributed in the United States.
The company has determined that certain TRUEread®, TRUEbalance®, TRUEtrack® and TRUEtest® blood glucose test strip lots packaged during a specific timeframe, may include open test strip vials within the sealed test strip vial boxes. Test strips contained within strip vials that remain open for long periods are exposed to the outside environment, which can affect strip performance. If a user does not notice an open test strip vial upon opening the sealed test strip vial box, and then uses the test strips to measure blood glucose, the meter may provide incorrect low blood glucose results.
There are 6 affected TRUEread lots, 56 TRUEtrack lots, 30 TRUEbalance lots and 160 TRUEtest test strip lots that were packaged from April 16, 2015 thru July 30, 2015 for sale in the United States.
We have not received any reports of patient injuries related to this voluntary recall.
Consumers who have TRUEread, TRUEtrack, TRUEbalance or TRUEtest test strips or TRUEread, TRUEtrack, TRUEbalance, TRUEresult or TRUE2go blood glucose meter kits that contain test strips should:
- Check whether you have an affected vial of TRUEread, TRUEtrack, TRUEbalance or TRUEtest test strips by obtaining the test strip lot number printed on the side of the test strip box or on the test strip vial label, by obtaining the meter kit lot number on the side of the TRUEread, TRUEtrack, TRUEbalance, TRUEresult or TRUE2go meter kit box which may contain affected test strips. Then visit www.trividiahealth.com/product-notice or call Stericycle toll-free at 1-888-835-2723 to determine if you have affected product.
- If you have any affected vials of TRUEread, TRUEtrack, TRUEbalance or TRUEtest test strips, please call Stericycle to verify the affected lot number, and to expedite return and replacement of test strips at no charge.
Consumers may continue to use test strips under these brands for lot numbers not included in this voluntary recall.
The company is sending notifications to pharmacies, durable medical equipment providers, mail order companies and distributors where the TRUEread, TRUEtrack, TRUEbalance or TRUEtest test strips are recommended or sold in the United States.
Patient safety is a top priority at Trividia Health. The company has notified the U.S. Food and Drug Administration (FDA) of this voluntary product recall to quickly resolve this matter.
About Trividia Health, Inc.: Trividia Health, Inc., a wholly owned subsidiary of Sinocare Group, is a global health and wellness company based in Fort Lauderdale, Florida and a leading developer, manufacturer and marketer of advanced performance products for people with diabetes. With products sold under TRUE and store brand labels, the company is the exclusive partner and supplier of affordable, high-quality blood glucose monitoring and health and wellness solutions for the world’s leading retail pharmacies, distributors and mail service providers. For more information, please visit: www.TrividiaHealth.com.
Trividia Health, Inc.
Lisa Nardi, (800) 342-7226, ext. 2183
Vice President, Marketing
www.trividiahealth.com