| 2026-02-06 |
Class I
|
Ongoing |
Z-1548-2026 |
Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description… |
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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… |
| 2026-02-06 |
Class I
|
Ongoing |
Z-1547-2026 |
Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description… |
— |
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… |
| 2026-02-06 |
Class I
|
Ongoing |
Z-1546-2026 |
Owner's Booklets and Instructions for Use that are used with the following blood glucose measurement devices. Descripti… |
— |
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… |
| 2026-02-06 |
Class I
|
Ongoing |
Z-1545-2026 |
Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Descriptio… |
— |
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… |
| 2025-10-07 |
Class II
|
Ongoing |
Z-0413-2026 |
Good Neighbor Pharmacy, TRUE METRIX Self Monitoring Blood Glucose Meter. Model/Catalog Number: RE4011-01. |
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Manufacturing defect causing LCD display issues with missing or partial segments (ghosting) that can result in misreading glucose values, potentially leading to… |
| 2020-04-20 |
Class II
|
Terminated |
Z-2201-2020 |
TRUE METRIX SELF MONITORING BLOOD GLUCOSE SYSTEM - Product Usage: is intended for the quantitative measurement of glucos… |
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One (1) TRUE METRIX AIR blood glucose meter distributed in the United States was packaged into a TRUE METRIX blood glucose meter kit and has an incorrect factor… |