True Metrix Self-Monitoring Blood Glucose System, True Metrix Pro Professional Monitoring Blood Glucose System

510(k) K140100

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK140100	Date1 Aug 2014Cleared	StatusActive

3 recalls · 3 ongoing · FDA

2 recalls, same reason
- Ongoing Z-1546-2026 FDA Class I initiated 6 Feb 2026
- Ongoing Z-1545-2026 FDA Class I initiated 6 Feb 2026
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.
- Ongoing Z-0413-2026 FDA Class II initiated 7 Oct 2025
Manufacturing defect causing LCD display issues with missing or partial segments (ghosting) that can result in misreading glucose values, potentially leading to inappropriate treatment decisions for diabetes management.

1 jurisdiction

United States — FDA 510(k) Active

510(k)