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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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…
- Manufacturer
- Trividia Health
Distribution
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 →Related recalls
Same manufacturer · Trividia Health
See all →- HighTrividia Health Recalls TRUEread Blood Glucose Test Strips for Inaccurate Readings
FDA (Devices) · 2016-10-05
- SevereTrividia Health Recalls TRUEread Blood Glucose Test Strips for Incorrect Readings
FDA (Devices) · 2016-10-05
- HighTrividia Health Recalls TRUEread Blood Glucose Test Strips for Inaccurate Readings
FDA (Devices) · 2016-10-05
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