FDA Device Recall Z-1947-2026

North American Rescue LLC. · Greer, SC

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death.

Device

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).

Lot / serial / GTIN: Kit REF/UDI-DI/Lot: 85-4661/00842209132089/85-4661122024; 85-4742/00842209133536/85-4742123024. Meter: UDI-DI: 20612479197217, all lots.

Quantity: 21

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.

Recall record

Recall number: Z-1947-2026
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Distribution: US: CA, WA
Recall initiated: 2026-03-27
Classified by FDA Center: 2026-04-29
FDA published: 2026-05-06
Recalling firm: North American Rescue LLC.
Firm location: Greer, SC

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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