TRUE METRIX TRUE METRIX self monitoring blood glucose meter (REF RE4001-01)Recalls & reported problems
Trividia Health, Inc. · Well at Walgreens TRUE METRIX self monitoring blood glucose meter · Class 2
All models of TRUE METRIX (31)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Feb 6, 2026Class IOpen, Classified
The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose.
Z-1545-2026 · Root cause: Software design · Recall details · FDA record ↗
Other System, Test, Blood Glucose, Over The Counter devices
- OneTouch Verio Flex 023-271LifeScan Europe GmbH · SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER3,703 reports
- FreeStyle Libre 2 71953Abbott Diabetes Care Inc · System, test, blood glucose, over the counter2 recalls1 death3,286 reports
- OneTouch Ultra2 021-105LifeScan U.S. LLC · SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER1,731 reports
- Omnipod DASH PDM PDM-USA1-D001-MG-USA1Insulet Corporation · System, Test, Blood Glucose, Over The Counter1 recall10 deaths1,129 reports
- Omnipod UST400Insulet Corporation · System, Test, Blood Glucose, Over The Counter12 deaths816 reports
- TRUE METRIX TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER - NOT FOR RETAIL SALETrividia Health, Inc. · System, Test, Blood Glucose, Over The Counter418 reports
- FreeStyle Freedom Lite 70923-70Abbott Diabetes Care Inc · SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER378 reports
- FreeStyle Lite 70829-70Abbott Diabetes Care Inc · SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER378 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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