Trividia Health, Inc. Initiates Voluntary Recall of Certain Lots of TRUEread®, TRUEbalance®, TRUEtrack® & TRUEtest® BLOOD GLUCOSE TEST STRIPS

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.

Contacts

Trividia Health, Inc.
Lisa Nardi, (800) 342-7226, ext. 2183
Vice
President, Marketing
www.trividiahealth.com

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