Trividia Health Recalls TRUEread Blood Glucose Test Strips for Incorrect Readings
Trividia Health is recalling TRUEread Blood Glucose Test Strips because they may provide incorrect low blood glucose levels, potentially affecting patient safety.
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. According to the rubric, an FDA Class II recall involving a medical device that provides incorrect diagnostic data (incorrect low blood glucose levels) poses a significant risk of harm, warranting a 'Severe' rating (Score 4).
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 providing incorrect low blood glucose levels. These strips are used to quantitatively measure whole blood glucose in professional settings or by self-testing.
The affected units include 5,527,921 items in total, comprising 4,621,639 strips and 393,808 kits domestically, and 500,058 strips and 22,416 kits internationally. Distribution was worldwide, including the United States (nationwide) and specific countries such as Austria, Bangladesh, Cambodia, Canada, Pakistan, Sri Lanka, Thailand, Turkey, the United Kingdom, and Vietnam.
Consumers and healthcare providers should stop using the affected test strips and contact Trividia Health for further instructions or a replacement. The specific lot numbers affected are listed in the official recall documentation.
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 →- HighTrividia Health Recalls TRUEread Blood Glucose Test Strips for Inaccurate 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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