AIDBAGs are first aid kits of convenience composed recalled

Timeline

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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).

Where it was distributed

US: CA, WA

CaliforniaWashington