FDA recall Z-0413-2026

Trividia Health, Inc. · Class II · device

Product

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.

Distribution

US Nationwide distribution in the states of NY, VA, FL, OH, CA, KY, NC.

Key facts

Status
Ongoing
Initiation date
2025-10-07
Report date
2025-11-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Ft Lauderdale, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0413-2026