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FDA · Medical devicesClass I

North American Rescue LLC. medical device recall: AIDBAGs are first aid kits of convenience composed of individually…

LeadSoftware problems

Key facts

Agency
U.S. Food and Drug Administration (FDA)
Program
Medical devices
Classification
Class I
Status
Ongoing
Event ID
98697
Recall initiated
Mar 27, 2026
Classified by FDA
Apr 29, 2026
Posted in Enforcement Report
May 6, 2026
Recalling firm
North American Rescue LLC.
Firm location
Greer, SC, United States
Initiated by
Voluntary: Firm initiated
Products in this event
1

What to do

Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.

View the official FDA record ↗

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.

What the classification means

  • Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.

About this recall

The firm started this recall on Mar 27, 2026. FDA classified it 33 days later, on Apr 29, 2026. Distribution reported by FDA: US: CA, WA North American Rescue LLC. has 5 recalls in our records.

Recalled products (1)

  • Z-1947-2026 Class I Ongoing

    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).

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

    Quantity: 21

Source and freshness

Source
U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
Official notice
FDA Enforcement Report, event 98697
Raw record
openFDA API (JSON)
Dataset last updated by FDA
Nov 3, 2026
Imported by RecallRadar
Nov 4, 2026

Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.