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Open, Classified

AIDBAGs are first aid kits of convenience composed of individually labeled devices designed as specialty first aid kits designed for the appropriate level provider to evaluate and treat patients at the point-of-injury / point-of-illness. The original manufacturer labeling, including single use indications, is maintained for each device, which may be used independently and at different times. These specific kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that were recalled as part of RES 98317 with (510(k): K140100).

FDA Recall Z-1947-2026 · Posted 2026-04-29

Recall StatusOpen, Classified
Product CodeLRR
Date Initiated2026-03-27
Product Quantity21

Reason for Recall

Kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that has been recalled for an issue with the software design of the E-5 Error Code where the meter displays an E-5 error code for a very high blood glucose event (> 600 mg/dL) or when there is a test strip error, which can lead to operator confusion when evaluating patients and a delay in appropriate treatment. This is a downstream recall of Trividia Health Class I, Recall Event ID 98317.

Firm Action

On 3/27/2026, correction notices were emailed to customers asking them to take the following actions: For Health Care Professions: Notify your providers and patients who use the products. You may use the customer notice on page 5. For Multiple Patient Facilities: Please post the notice provided on page 6 in areas where the Products are stored within your facility to notify personnel of this labeling correction. For People with Diabetes: Follow the updated E-5 error code instructions in the notice on page 5. This correction should be carried out to the user level. If you have further distributed this product, notify them of this correction. Your notification may be enhanced by including this correction notification letter. Customers with questions can contact Trividia Health Customer Care at 1-888-835-2723, Monday-Friday 8AM-8PM EST (excluding holidays) or email. For links to the updated Owner's Booklets and help resources visit www.trividiahealth.com [email protected] The notice provides email www.NARercue.com

Root Cause

Component design/selection

Distribution Pattern

US: CA, WA

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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