| | Class 1 Device Recall KIT, AIDBAG SMALL CRISIS 24 (REF: 854661)
KIT, AIDBAG 1 V1.0 SEATTLE PD (REF: 854742). |  |
| Date Initiated by Firm | March 27, 2026 |
| Date Posted | April 29, 2026 |
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1947-2026 |
| Recall Event ID |
98697 |
| Product Classification |
First Aid Kit with drug - Product Code LRR
|
| 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). |
| Code Information |
Kit REF/UDI-DI/Lot:
85-4661/00842209132089/85-4661122024;
85-4742/00842209133536/85-4742123024.
Meter: UDI-DI: 20612479197217, all lots. |
| FEI Number |
3005034064
|
Recalling Firm/ Manufacturer |
North American Rescue LLC. 35 Tedwall Ct Greer SC 29650-4791
|
| For Additional Information Contact | 864-675-9800 |
Manufacturer 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. |
FDA Determined Cause 2 | Component design/selection |
| 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 trividia0126CC@trividiahealth.com
The notice provides email www.NARercue.com |
| Quantity in Commerce | 21 |
| Distribution | US: CA, WA |
| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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