Recall Z-0413-2026 ยท NBW System, Test, Blood Glucose, Over The Counter
Trividia Health, Inc.
Good Neighbor Pharmacy, TRUE METRIX Self Monitoring Blood Glucose Meter. Model/Catalog Number: RE4011-01.
| Date | Oct 30, 2025 (initiated Oct 7, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Device Design |
| Action | Trividia Health notified consignees on about 10/07/2025 via email, letter and press release. Distributors were instructed to examine inventory for affected meters by reviewing the lot number printed on the outer case/shipper label or on the side of the Product's box. Affected units were directed to be returned per normal return procedures. Additionally, they were instructed to notify customers of the recall and request that they return affected units to the distributor. Pharmacists/DME Providers were instructed to examine inventory for affected meters reviewing the lot number in the same m |
| Quantity | 601 units |
| Distribution | US Nationwide distribution in the states of NY, VA, FL, OH, CA, KY, NC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140100 | TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PRO PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM Nipro Diagnostics, Inc., Aug 1, 2014 |