Recall Z-0413-2026— Trividia Health, Inc.

Name: FDA recall Z-0413-2026
Creator: U.S. Food and Drug Administration
Published: 2025-10-07

Class II · Ongoing

Class II FDA medical device recall by Trividia Health, Inc., initiated 2025-10-07. It names one FDA 510(k) clearance: K140100. Product: Good Neighbor Pharmacy, TRUE METRIX Self Monitoring Blood Glucose Meter. Model/Catalog Number: RE4011-01.. Reason: 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..

Recalling firm: Trividia Health, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-10-07
Firm location: Ft Lauderdale, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K140100 — TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PRO PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEMNipro Diagnostics, Inc.·cleared 2014-08-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Good Neighbor Pharmacy, TRUE METRIX Self Monitoring Blood Glucose Meter. Model/Catalog Number: RE4011-01.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.