TRUE METRIX SELF MONITORING BLOOD GLUCOSE SYSTEM - Product Usage: is intended for the quantitativ...
FDA Device Recall #Z-2201-2020 — Class II — April 20, 2020
Recall Summary
| Recall Number | Z-2201-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 20, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Trividia Health, Inc. |
| Location | Ft Lauderdale, FL |
| Product Type | Devices |
| Quantity | 1 unit |
Product Description
TRUE METRIX SELF MONITORING BLOOD GLUCOSE SYSTEM - Product Usage: is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm.
Reason for Recall
One (1) TRUE METRIX AIR blood glucose meter distributed in the United States was packaged into a TRUE METRIX blood glucose meter kit and has an incorrect factory-set unit of measure; the meter displays glucose results in mmol/L rather than mg/dL.
Distribution Pattern
US Nationwide distribution including in the state of Florida.
Lot / Code Information
Serial Number TA1548753
Other Recalls from Trividia Health, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1546-2026 | Class I | Owner's Booklets and Instructions for Use that ... | Feb 6, 2026 |
| Z-1547-2026 | Class I | Owner's Booklets and Instructions for Use that ... | Feb 6, 2026 |
| Z-1548-2026 | Class I | Owner's Booklets and Instructions for Use that ... | Feb 6, 2026 |
| Z-1545-2026 | Class I | Owner's Booklets and Instructions for Use that ... | Feb 6, 2026 |
| Z-0413-2026 | Class II | Good Neighbor Pharmacy, TRUE METRIX Self Monito... | Oct 7, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.