AIDBAGs are first aid kits of convenience composed of individually labeled devic...
Reason for Recall / 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.
Product Description & Identification
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).
Additional Source Details
| Field | Value |
|---|---|
| City | Greer |
| State | SC |
| Event id | 98697 |
| Address 1 | 35 Tedwall Ct |
| Code info | Kit REF/UDI-DI/Lot: 85-4661/00842209132089/85-4661122024; 85-4742/00842209133536/85-4742123024. Meter: UDI-DI: 20612479197217, all lots. |
| Postal code | 29650-4791 |
| Report date | 20260506 |
| Product type | Devices |
| Product 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260327 |
| Center classification date | 20260429 |
Overview
- Recalling FirmNorth American Rescue LLC.
- StatusOngoing
- Risk LevelClass I
- DistributionUS: CA, WA