FDA Device recall Z-1947-2026
AIDBAGs are first aid kits of convenience composed of individually labeled devices designed as specialty first aid kits designed for the ap…
- FDA Device
- Class I
- ongoing
- Published 2026-05-06
On 2026-05-06 the FDA classified a Class I recall of AIDBAGs are first aid kits of convenience composed of individually labeled devices designed as specialty first aid kits designed for the ap… by North American Rescue, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1947-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2026-03-27 |
| Published | 2026-05-06 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | North American Rescue |
| Distribution | CA, WA |
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
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.
Identifiers
| code_info | Kit REF/UDI-DI/Lot: 85-4661/00842209132089/85-4661122024; 85-4742/00842209133536/85-4742123024. Meter: UDI-DI: 20612479197217, all lots. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1947-2026%22
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