TRUE METRIX SELF MONITORING BLOOD GLUCOSE SYSTEM — Class II medical device recall Z-2201-2020
Terminated recall by Trividia Health, Inc., reported 2020-06-10, distributed nationwide. One (1) TRUE METRIX AIR blood glucose meter distributed in the United States was packaged into a TRUE METRIX b
| Recall number | Z-2201-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Trividia Health, Inc., Ft Lauderdale, FL, United States |
| Recall initiated | 2020-04-20 |
| Classified | 2020-06-01 |
| Reported by FDA | 2020-06-10 |
| Terminated | 2021-06-01 |
| Distributed | Nationwide (US) |
| Quantity | 1 units |
| Serial numbers | TA1548753 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2201-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.