CLASS II Device recall · Reported 10 Jun 2020 · FDA Enforcement Report
True Metrix Self Monitoring Blood Glucose System recalled
Trividia Health is recalling True Metrix Self Monitoring Blood Glucose System, distributed nationwide in the US. The recall was initiated on 20 Apr 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2201-2020
- FDA event ID
- 85535
- Recalling firm
- Trividia Health, Ft Lauderdale, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Apr 2020
- FDA classified
- 1 Jun 2020
- Reported
- 10 Jun 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Packaging Defects
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 20 Apr 2020 | Recall initiated by company | |
| 1 Jun 2020 | Classified by FDA | +42 days |
| 10 Jun 2020 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution including in the state of Florida.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Serial Number TA1548753
Where was it sold?
US Nationwide distribution including in the state of Florida.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Trividia Health
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Owner's Booklets and Instructions for Use that are used recalled | Trividia Health | Device Malfunction | Nationwide |
| Device | CLASS I | Owner's Booklets and Instructions for Use that are used recalled | Trividia Health | Device Malfunction | Nationwide |
| Device | CLASS I | Owner's Booklets and Instructions for Use that are used recalled | Trividia Health | Device Malfunction | Nationwide |
| Device | CLASS I | Owner's Booklets and Instructions for Use that are used recalled | Trividia Health | Device Malfunction | Nationwide |
| Device | CLASS II | Good Neighbor Pharmacy, True Metrix Self Monitoring Blood recalled | Trividia Health | Device Malfunction | Nationwide |
Other Insulin Pumps & Glucose Monitors recalls
All 467| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | MiniMed Flex Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Labeling Errors | Nationwide |
| Device | CLASS II | Fisher Scientific Sure-Vue Urine hCG Strip recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |
| Device | ANNOUNCED | StatStrip Glucose Hospital Meter System recalled by Nova BiomedicalNova Biomedical StatStrip | Nova Biomedical | Device Malfunction | |
| Device | CLASS I | StatStrip Glucose Hospital Meter System recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |
| Device | CLASS I | StatStrip Glucose and B- Ketone meter recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |