The Recall Desk
HighFDA (Devices)·Z-2882-2016·Announced 2016-10-05

Trividia Health Recalls TRUEread Blood Glucose Test Strips for Inaccurate Readings

Trividia Health is recalling TRUEread Blood Glucose Test Strips because they may provide incorrect low blood glucose levels. The recall affects strips and kits distributed in the US and internationally.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves incorrect medical readings (low blood glucose) which poses a risk of harm, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Trividia Health is recalling TRUEread Blood Glucose Test Strips (Glucose Oxidase) used with TRUEresult and TRUE2go meters. The recall was initiated because the product gives incorrect low blood glucose levels. These strips are used to quantitatively measure whole blood glucose in professional settings or by self-testing.

The recall covers approximately 5.5 million units, including strips and kits, distributed nationwide in the United States and in several international countries. The affected products are identified by specific lot numbers listed in the official recall notice.

Consumers should stop using the affected test strips and contact Trividia Health for a refund or replacement. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

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
Manufacturer
Trividia Health

Distribution

Distributed nationwide across the United States.

The notice also names 47 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Trividia Health under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →