FDA Device recall Z-2201-2020
TRUE METRIX SELF MONITORING BLOOD GLUCOSE SYSTEM - Product Usage: is intended for the quantitative measurement of glucose (sugar) in fresh…
- FDA Device
- Class II
- terminated
- Published 2020-06-10
On 2020-06-10 the FDA classified a Class II recall of TRUE METRIX SELF MONITORING BLOOD GLUCOSE SYSTEM - Product Usage: is intended for the quantitative measurement of glucose (sugar) in fresh… by Trividia Health, citing 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 measu….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2201-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-04-20 |
| Published | 2020-06-10 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Trividia Health |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | Serial Number TA1548753 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2201-2020%22
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