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.
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 involves a medical device that provides incorrect low blood glucose levels, which poses a risk of harm to users managing diabetes, fitting the criteria for a high-risk product where injury has not yet been reported.
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 a defect where the product gives incorrect low blood glucose levels.
The affected product is available in vials of 10, 25, and 50 strips, as well as in kits sold with meters. The recall covers approximately 5.5 million units distributed domestically and internationally. Specific lot numbers for strips, kits, and prepackaged items are listed in the official recall notice.
Consumers should stop using the affected test strips and contact Trividia Health for a refund or replacement. The recall is classified as Class II by the FDA, indicating a reasonable probability that use of the product could cause temporary or medically reversible 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
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 →- 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
- SevereTrividia TRUEread Blood Glucose Test Strips Recalled for Incorrect Low Readings
FDA (Devices) · 2016-10-05
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