The Recall Desk
SevereFDA (Devices)·Z-2883-2016·Announced 2016-10-05

Trividia TRUEread Blood Glucose Test Strips Recalled for Incorrect Low Readings

Trividia Health is recalling TRUEread Blood Glucose Test Strips because they may provide incorrect low blood glucose levels.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves incorrect low blood glucose readings, which poses a significant risk of harm to patients managing diabetes.

Plain-English summary

Trividia Health is recalling TRUEread Blood Glucose Test Strips (Glucose Oxidase) used with TRUEresult and TRUE2go meters. The recall is due to the product giving incorrect low blood glucose levels.

The affected units include 5,527,921 strips and kits distributed worldwide, including nationwide in the United States and in specific countries such as Austria, Canada, and the United Kingdom. Specific lot numbers for strips, kits, and prepackaged items are listed in the official recall documentation.

Consumers should stop using the affected test strips and contact Trividia Health for a replacement or refund. Users should consult their healthcare provider for appropriate blood glucose monitoring alternatives.

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 →