FDA Recall 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).

Recall: Z-1947-2026 · Initiated March 27, 2026

Recall

Recall Number
Z-1947-2026
Event Number
98697
Firm
North American Rescue LLC.
FEI Number
3005034064
Product Code
LRR
Status
Open, Classified
Root Cause
Component design/selection
Initiated
March 27, 2026
Posted
April 29, 2026
Address
35 Tedwall Ct, Greer, SC, 29650-4791

Description

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).

Reason

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.

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

Distribution

US: CA, WA

Quantity

21