Recall Z-2882-2016— Trividia Health

Name: FDA recall Z-2882-2016
Creator: U.S. Food and Drug Administration
Published: 2016-06-28

Class II · Ongoing

Class II FDA medical device recall by Trividia Health, initiated 2016-06-28. It names one FDA 510(k) clearance: K042080. Product: TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters. TRUEread Blood Glucose Test Strips are available in vials with 10 ct., 25 ct., 50 ct., and sold as 10 ct. with meters. Quantitatively measure whole blood glucose in a professional setting or by self-testing.. Reason: Product gives incorrect low blood glucose levels..

Recalling firm: Trividia Health
Classification: Class II
Status: Ongoing
Initiated: 2016-06-28
Firm location: Fort Lauderdale, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K042080 — TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEMHome Diagnostics, Inc.·cleared 2004-08-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters. TRUEread Blood Glucose Test Strips are available in vials with 10 ct., 25 ct., 50 ct., and sold as 10 ct. with meters. Quantitatively measure whole blood glucose in a professional setting or by self-testing.

Reason for recall

Product gives incorrect low blood glucose levels.

Data sourced from openFDA. This site is unofficial and independent of the FDA.