Recall Z-2881-2016— Trividia Health
Class II · Ongoing
Class II FDA medical device recall by Trividia Health, initiated 2016-06-28. It names 2 FDA 510(k) clearances: K032657, K030703. 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 setting or by self-testing.. Reason: Product gives incorrect low blood glucose levels..
- Recalling firm
- Trividia Health
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2016-06-28
- Firm location
- Fort Lauderdale, FL, United States
510(k) clearances named in this recall
2 on FDA's record- K032657 — TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIPS, AND GLUCOSE CONTROL SOLUTIONS (LOW AND HIGH)
- K030703 — TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER AND TRUE TRACK SMART SYSTEM BLOOD GLUCOSE TEST STRIPS
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 setting or by self-testing.
Reason for recall
Product gives incorrect low blood glucose levels.
Data sourced from openFDA. This site is unofficial and independent of the FDA.