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North American Rescue LLC.: AIDBAGs are first aid kits of convenience composed of individually labeled devices designed as specialty first aid kits designed for the app

Medical DevicesSource: FDA (device) · Date: 2026-05-06

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
North American Rescue LLC.
Product
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 / hazard
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.
Classification
Class I
Status
Ongoing
Distribution / sold at
US: CA, WA
Recall initiated
2026-03-27
Code info
Kit REF/UDI-DI/Lot: 85-4661/00842209132089/85-4661122024; 85-4742/00842209133536/85-4742123024. Meter: UDI-DI: 20612479197217, all lots.
Product quantity
21
Voluntary mandated
Voluntary: Firm initiated
City
Greer
State
SC
Country
United States
Event id
98697
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